The DOI matches its Crossref record; 118 of the 118 references it cites were found in a registry or an index; 7 of the 178 sources its claims cite were checked for support.
Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook
Open accessAbstract
The community of microorganisms within the human gut (or microbiota) is critical to health and functions with a level of complexity comparable to that of an organ system. Alterations of this ecology (or dysbiosis) have been implicated in a number of disease states, and the prototypical example is Clostridium difficile infection (CDI). Fecal microbiota transplantation (FMT) has been demonstrated to durably alter the gut microbiota of the recipient and has shown efficacy in the treatment of patients with recurrent CDI. There is hope that FMT may eventually prove beneficial for the treatment of other diseases associated with alterations in gut microbiota, such as inflammatory bowel disease, irritable bowel syndrome, and metabolic syndrome, to name a few. Although the basic principles that underlie the mechanisms by which FMT shows therapeutic efficacy in CDI are becoming apparent, further research is needed to understand the possible role of FMT in these other conditions. Although relatively simple to perform, questions regarding both short-term and long-term safety as well as the complex and rapidly evolving regulatory landscape has limited widespread use. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current "whole-stool" transplants to increase safety and tolerability. Encapsulated formulations, full-spectrum stool-based products, and defined microbial consortia are all in the immediate future.
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Claims the paper makes
112 Not checked yet · 43 No basis given · 27 Own interpretation · 3 Couldn’t confirm · 2 Supported so far · 1 Own method · accuracy not yet measured
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Indeed, studies have demonstrated that patients suffering from recurrent CDI are deficient in phyla of bacteria normally dominant in the colon6,45 (Figure 1).”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Supportedcites [6] Khoruts, 2010, Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea, J Clin Gastroenterol source
The Discussion reports that the patient with recurrent CDAD was deficient in Firmicutes and Bacteroidetes before treatment and identifies these as normally dominant bacterial divisions. That directly supports the finding for which this study is cited. (LLM, conf=0.92)
- Not checked yetcites [45] Rupnik, 2009, Clostridium difficile infection: new developments in epidemiology and pathogenesis, Nat Rev Microbiol source
boostedcorrelational- Asserted: passes — The authors put it forward as true.
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- Supported
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“Weingarden and colleagues reported an increase in secondary bile acids following FMT compared to pre-transplant stool samples.19”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Could not verifycites [19] Weingarden, 2013, Resolution of severe Clostridium difficile infection following sequential fecal microbiota transplantation, J Clin Gastroenterol sourceExperimental — accuracy not yet measured
The case-series description and Discussion (page unavailable) report clinical responses to FMT in four patients with severe CDI, but do not report stool bile-acid measurements or a pre- versus post-transplant comparison. Searches for “secondary bile acids,” “bile acids,” and “pre-transplant stool samples” found no passage addressing the claimed increase. (LLM, conf=0.76)
plaindirect- Asserted: passes — The authors put it forward as true.
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- Could not verify
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“In 2010, Russell et al. report the first pediatric patient treated with FMT via nasogastric tube.118”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Could not verifycites [118] Petrof, 2013, Stool substitute transplant therapy for the eradication of Clostridium difficile infection: ‘RePOOPulating’ the gut, Microbiome sourceExperimental — accuracy not yet measured
The Abstract (Background) describes two patients treated with a stool substitute by colonoscopy, not a pediatric patient treated by nasogastric tube. A search of our copy for Russell, pediatric FMT, and nasogastric delivery found no account of the claimed 2010 case; the References list Russell only as an author of a 2011 work. (LLM, conf=0.75)
plainSingle case- Asserted: passes — The authors put it forward as true.
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In the paper
“A more recent study in mice treated with the antibiotic cefoperazone suggests that antibiotic treatment alters the fecal metabolome related to microbial function.48”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [48] Khanna, 2012, The epidemiology of community-acquired Clostridium difficile infection: a population-based study, Am J Gastroenterol source
hedgedconditional- Asserted: passes — The authors put it forward as true.
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In the paper
“and administration of a cocktail containing a member of Lachnospiraceae was reported to cure CDI in mice52.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [52] Rea, 2010, Thuricin CD, a posttranslationally modified bacteriocin with a narrow spectrum of activity against Clostridium difficile, Proc Natl Acad Sci U S A source
plaindirect- Asserted: passes — The authors put it forward as true.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Published data do not demonstrate a significant difference in success with FMT whether the donor stool is mixed in tap water, milk, or normal saline (sterile, nonbacteriostatic), although the latter is presumed to be less likely to affect the microbiota of the donor specimen.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Stool Preparation and Methods of Administration
boosted- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Numerous case reports, retrospective case series and a single randomized controlled trial have demonstrated benefit of FMT in patients with severe or recurrent CDI with cure rates as high as 100% and a mean cure rate of 87–90% for the over 500 cases reported in the world literature to date.3–5”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Introduction
What the sources say
- Not checked yetcites [3] Cammarota, 2014, Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review, J Clin Gastroenterol source
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
- Not checked yetcites [5] Kassam, 2013, Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis, Am J Gastroenterol source
boosteddirectn = 500- Asserted: passes — The authors put it forward as true.
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In the paper
“it is likely other members of the gut microbiota secrete similar antimicrobials.53”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [53] Buffie, 2015, Precision microbiome reconstitution restores bile acid mediated resistance to Clostridium difficile, Nature source
hedgedconditional- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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In the paper
“Conversely, a small, open label pilot study comparing upper and lower GI routes of administration did not show any differences44”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [44] Chang, 2008, Decreased diversity of the fecal microbiome in recurrent Clostridium difficile associated diarrhea, J Infect Dis source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“While antibiotics are a major risk factor for CDI, community acquired CDI is becoming increasingly common in the absence of antibiotic use.49”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [49] Shahinas, 2012, Toward an understanding of changes in diversity associated with fecal microbiome transplantation based on 16S rRNA gene deep sequencing, mBio source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“A more recent study by Butte et al. showed treatment with either a consortium of bacteria or C. scindens both of which harbor the gene encoding 7-hydroxysteroid dehydrogenase required for secondary bile acid synthesis can ameliorate CDI in mice.54”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [54] Wallis, 1909, The surgery of colitis, Br Med J source
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“The greatest risk factor for CDI is the use of antibiotics,46 though only a small proportion of patients on antibiotics develop the infection.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [46] Dethlefsen, 2008, The pervasive effects of an antibiotic on the human gut microbiota, as revealed by deep 16S rRNA sequencing, PLoS Biol source
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“Additionally, changes in microbial community structure such as restoration of key Firmicutes and Bacteroidetes species with a decrease in Proteobacteria appear to be required in order to outcompete C. difficile.50”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [50] Reeves, 2012, Suppression of Clostridium difficile in the gastrointestinal tracts of germfree mice inoculated with a murine isolate from the family Lachnospiraceae, Infect Immun source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At this time, limited data are available to suggest that any factors other than specific exclusion criteria based on medical history and laboratory testing would endorse a particular donor as optimal.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Donor selection
hedged- Asserted: passes — The authors put it forward as true.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As with preparation of the stool, there is no clear consensus on the best method of instillation.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Stool Preparation and Methods of Administration
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“A recent open-label, single group study23 at Massachusetts General Hospital assessed the efficacy of fecal material from healthy donors administered as 15 frozen pills on two consecutive days in patients with relapsing CDI. They reported an overall 90% response rate making oral administration a viable alternative to the current practice of administering fecal material via an endoscopic procedure”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [23] Youngster, 2014, Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection, JAMA source
plaindirect- Asserted: passes — The authors put it forward as true.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The evidence supporting FMT for treatment of severe, complicated disease (e.g. toxic megacolon) is less robust, with fewer published cases, however a few case reports suggest that it may be safe and effective even in critically ill patients18–21.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Indications
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“Indeed, directed blood donors have higher viral marker rates than volunteer donors.22”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Donor selection
What the sources say
- Not checked yetcites [22] Dorsey, 2013, A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010, Transfusion source
plaincorrelational- Asserted: passes — The authors put it forward as true.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“FMT is reported to be effective by all of these routes, and the preferred method may vary with the clinical situation.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Stool Preparation and Methods of Administration
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“Bacillus thuringensis secretes a bacteriocin, thuricin CD, with narrow spectrum activity against gram positive bacteria including C. difficile; it is likely other members of the gut microbiota secrete similar antimicrobials.53”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [53] Buffie, 2015, Precision microbiome reconstitution restores bile acid mediated resistance to Clostridium difficile, Nature source
plaindirect- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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In the paper
“This study was terminated early by the safety monitoring board because it was deemed unethical to continue subjecting patients to the inferior treatment.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
plaindirect- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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In the paper
“An important factor determining success of fecal transplant is restoration of microbial diversity following treatment50.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [50] Reeves, 2012, Suppression of Clostridium difficile in the gastrointestinal tracts of germfree mice inoculated with a murine isolate from the family Lachnospiraceae, Infect Immun source
plaindirect- Asserted: passes — The authors put it forward as true.
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In the paper
“There has, to date, been only a single randomized controlled trial4.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“suggesting the increased weight gain is not simply from increased energy harvest but rather an effect on the gut neuro-hormonal axis increasing energy expenditure or pathways affecting satiety.83”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [83] Vrieze, 2012, Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome, Gastroenterology source
hedgedconditional- Asserted: passes — The authors put it forward as true.
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In the paper
“There was no statistically significant difference in clinical and endoscopic remission between the two groups.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [78] James, 2001, The worldwide obesity epidemic, Obes Res source
plainn = 50- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Several studies have found alterations in the gut microbiome in patients with IBS.86–89”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [86] Balsari, 1982, The fecal microbial population in the irritable bowel syndrome, Microbiologica
- Not checked yetcites [87] Malinen, 2005, Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR, Am J Gastroenterol source
- Not checked yetcites [88] Simren, 2013, Intestinal microbiota in functional bowel disorders: a Rome Foundation report, Gut source
- Not checked yetcites [89] Crouzet, 2013, The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota, Neurogastroenterol Motil source
plaincorrelational- Asserted: passes — The authors put it forward as true.
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In the paper
“It is likely that this study was underpowered to detect these differences.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [78] James, 2001, The worldwide obesity epidemic, Obes Res source
hedgedn = 50- Asserted: passes — The authors put it forward as true.
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In the paper
“Transfer of gut microbiota from lean and obese individuals can recapitulate the metabolic phenotype in ex-germ free mice.14”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [14] Ridaura, 2013, Gut microbiota from twins discordant for obesity modulate metabolism in mice, Science source
plaindirect- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Several lines of evidence support the role of gut microbiota in obesity.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [80] Cho, 2012, Antibiotics in early life alter the murine colonic microbiome and adiposity, Nature source
- Not checked yetcites [14] Ridaura, 2013, Gut microbiota from twins discordant for obesity modulate metabolism in mice, Science source
- Not checked yetcites [81] Liou, 2013, Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity, Sci Transl Med source
plaincorrelational- Asserted: passes — The authors put it forward as true.
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In the paper
“Some UC patients worsened in one study of FMT71.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [71] Landy, 2013, A prospective controlled pilot study of fecal microbiota transplantation for chronic refractory pouchitis, Gastroenterology source
plaindirect- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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In the paper
“transfer of gut microbiota following roux-en-y gastric bypass to germ free mice leads to weight loss compared to microbiota from sham surgery.82”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [82] Walker, 2013, Microbiology. Fighting obesity with bacteria, Science source
plaindirect- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“Advanced molecular techniques have demonstrated fundamental differences in both microbial composition and function in patients with IBD.56–58”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [56] Kostic, 2014, The microbiome in inflammatory bowel disease: current status and the future ahead, Gastroenterology source
- Not checked yetcites [57] Manichanh, 2012, The gut microbiota in IBD, Nat Rev Gastroenterol Hepatol source
- Not checked yetcites [58] Frank, 2007, Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases, Proc Natl Acad Sci U S A source
boostedcorrelational- Asserted: passes — The authors put it forward as true.
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In the paper
“Studies have also shown lower levels of the protective Faecalibacterium prausnitzii, which has been associated with anti-inflammatory properties in patients with Crohn’s diseases.60”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [60] Bennet, 1989, Treatment of ulcerative colitis by implantation of normal colonic flora, Lancet source
plaincorrelational- Asserted: passes — The authors put it forward as true.
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None of the sources cited for this claim have been checked yet.
In the paper
“These reports were followed by a number of small studies of FMT in children and adults with UC, CD, and pouchitis with mixed results.64–72”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [64] Damman, 2014, Single colonoscopically administered fecal microbiota transplant for ulcerative colitis—a pilot study to determine therapeutic benefit and graft stability, Gastroenterology source
- Not checked yetcites [65] Vaughn, 2014, Fecal microbiota transplantation induces early improvement in symptoms in patients with active Crohn's disease (abstr), Gastroenterology source
- Not checked yetcites [66] Suskind, 2015, Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis, J Pediatr Gastroenterol Nutr source
- Not checked yetcites [67] Vermeire, 2012, Pilot study on the safety and efficacy of faecal microbiota transplantation in refractory Crohn's disease, Gastroenterology source
- Not checked yetcites [68] Kunde, 2013, Safety, tolerability, and clinical response after fecal transplantation in children and young adults with ulcerative colitis, J Pediatr Gastroenterol Nutr source
- Not checked yetcites [69] Kump, 2013, Alteration of intestinal dysbiosis by fecal microbiota transplantation does not induce remission in patients with chronic active ulcerative colitis, Inflamm Bowel Dis source
- Not checked yetcites [70] Angelberger, 2013, Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation, Am J Gastroenterol source
- Not checked yetcites [71] Landy, 2013, A prospective controlled pilot study of fecal microbiota transplantation for chronic refractory pouchitis, Gastroenterology source
- Not checked yetcites [72] Colman, 2014, Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis, J Crohns Colitis source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“microbiota from lean mice produce greater amounts of short chain fatty acids than those from obese mice”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [83] Vrieze, 2012, Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome, Gastroenterology source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These initial mixed results do not rule out a possible role of FMT or other gut-microbiota products in the management of IBD.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
hedgedconditional- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although the microbial basis of IBD is far more complex and variable than that of recurrent/refractory CDI, microbiome-based therapies are an important area of investigation for these chronic and debilitating diseases.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Lean and obese individuals show marked differences in the gut microbiome.80”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [80] Cho, 2012, Antibiotics in early life alter the murine colonic microbiome and adiposity, Nature source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“A recent systematic review and meta-analysis of 18 studies that included 122 patients with IBD who received FMT found a 45% clinical remission rate.73”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [73] Suskind, 2015, Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease, Inflamm Bowel Dis source
plainn = 122- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“However, the remission rate fell to 36.2% when the case series were excluded in order to minimize publication bias.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [73] Suskind, 2015, Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease, Inflamm Bowel Dis source
plaindirectn = 122- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“UC patients were much less likely to achieve clinical remission (22%).”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [73] Suskind, 2015, Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease, Inflamm Bowel Dis source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Remission (full Mayo score <3 and complete mucosal healing) was achieved in 24% of patients after FMT and 5% with placebo; stool from patients receiving FMT had greater microbial diversity than that of patients given placebo.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [77] Rossen, 2015, Findings from a randomized controlled trial of fecal transplantation for patients with ulcerative colitis, Gastroenterology source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Antibiotic treatment in early life predisposes to obesity in animal models81”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [81] Liou, 2013, Conserved shifts in the gut microbiota due to gastric bypass reduce host weight and adiposity, Sci Transl Med source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“This pilot study is proof of principle for future randomized controlled trials using fecal transplant or defined microbial consortia for treatment of obesity, metabolic syndrome and diabetes.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
What the sources say
- Not checked yetcites [84] Hungin, 2005, Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact, Aliment Pharmacol Ther source
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“A few early studies94 reported improvement in patients with IBS following FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [94] ClinicalTrials.gov. Fecal microbiota transplantation in HIV. Available at: https://clinicaltrials.gov/ct2/results?term=hiv+fmt&Search=Search. Accessed May 1, 2015.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“there were no infectious complications related to FMT in these potentially “at risk” patients.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Another potential episode of transmission comes from a case report of fever and E. coli bacteremia 24 hours after FMT via colonoscopy in a patient with IBD108.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [108] Russell, 2014, Fecal transplant for recurrent Clostridium difficile infection in children with and without inflammatory bowel disease, J Pediatr Gastroenterol Nutr source
hedgedcorrelationalSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“A consistent finding has been decreased microbial diversity, a finding which is reminiscent of alterations in patients with CDI, IBD and obesity.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“One center reported 2 cases of documented norovirus infection 2 days and 12 days after FMT107.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [107] Kahn, 2012, Colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection in a child, Am J Gastroenterol source
plainn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“transplantation of human fecal microbiota from obese individuals to rodents has been shown to transmit an obesity phenotype109”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
What the sources say
- Not checked yetcites [109] Vandenplas, 2014, Fecal microbial transplantation in a one-year-old girl with early onset colitis—caution advised, J Pediatr Gastroenterol Nutr
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Thus, legitimate concern exists regarding the long-term risk of FMT transplantation, especially when used for indications with less well-documented benefit than recurrent CDI.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Although other serious adverse events have been reported with FMT (e.g., peritonitis in a patient undergoing peritoneal dialysis, pneumonia, IBD flares), their relationship to FMT is uncertain.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Many are willing to travel great distances to undergo FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: Many patients are willing to travel great distances to undergo FMT.
In the paper
“FMT from lean individuals to obese subjects with metabolic syndrome showed an increase in insulin sensitivity110.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
What the sources say
- Not checked yetcites [110] Pierog, 2014, Fecal microbiota transplantation in children with recurrent Clostridium difficile infection, Pediatr Infect Dis J source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Minor symptoms immediately following FMT are common, and include abdominal discomfort, bloating, flatulence, diarrhea, constipation, borborygmia, vomiting, and transient fever4, 70, 71, 78.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
- Not checked yetcites [70] Angelberger, 2013, Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation, Am J Gastroenterol source
- Not checked yetcites [71] Landy, 2013, A prospective controlled pilot study of fecal microbiota transplantation for chronic refractory pouchitis, Gastroenterology source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“A partial list of conditions that have been linked to the gut microbiota includes obesity, diabetes, atherosclerosis, IBD, colon cancer, non-alcoholic fatty liver disease, irritable bowel syndrome, asthma, and autism.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“However, any conclusion regarding short-term safety must be viewed with caution since the data come primarily from retrospective case series with variable assessment and follow-up for adverse events.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Kelly, et al recently published a multicenter retrospective study of immunocompromised patients who underwent FMT to treat CDI.43”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“recent studies suggest that changes in the gut microbiota may be responsible for underlying mechanisms associated with IBS such as visceral hypersensitivity, altered barrier function, gastrointestinal motility and the gut-brain axis90–93.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [90] Kashyap, 2013, Complex interactions among diet, gastrointestinal transit, and gut microbiota in humanized mice, Gastroenterology source
- Not checked yetcites [91] Collins, 2012, The interplay between the intestinal microbiota and the brain, Nat Rev Microbiol source
- Not checked yetcites [92] Grover, 2014, On the fiftieth anniversary. Postinfectious irritable bowel syndrome: mechanisms related to pathogens, Neurogastroenterol Motil source
- Not checked yetcites [93] Andrews, 1995, Bacteriotherapy for chronic constipation—long term follow up, Gastroenterology source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“While these early reports are encouraging, it is important to remember that they are from small, uncontrolled series with high risk of bias.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [94] ClinicalTrials.gov. Fecal microbiota transplantation in HIV. Available at: https://clinicaltrials.gov/ct2/results?term=hiv+fmt&Search=Search. Accessed May 1, 2015.
- Not checked yetcites [95] Hamilton MJ, Weingarden AR, Sadowsky MJ, et al. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol;107:761–767. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Only one prospective randomized controlled trial is available to compare adverse events with FMT vs. a control group4.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
plainn = 16- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Evidence regarding the safety of FMT is relatively limited because the very rapid adoption of FMT as a therapeutic modality for CDI has occurred prior to the performance of large, long prospective trials”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The greater concern regarding FMT relates to long-term safety.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Very little information is available regarding the long-term safety of FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Thus, gut microbiota is an important target for study in the treatment of functional disorders such as IBS”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [89] Crouzet, 2013, The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota, Neurogastroenterol Motil source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“several currently used therapies, such as pre and probiotics, dietary restrictions and antibiotics, modulate the gut microbiota.89”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [89] Crouzet, 2013, The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota, Neurogastroenterol Motil source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“More serious adverse events related to the procedure used to administer the FMT, although rare, may occur.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“determining if adverse events are related to FMT is often difficult because patients who receive FMT for recurrent CDI commonly are ill with other comorbidities.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“With the advent of more aesthetically acceptable protocols, including odorless pills, FMT is likely to appeal to a majority of patients who are deemed eligible for FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
hedgedconditionaln = 77- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Similarly, uncontrolled data on FMT as a primary treatment for IBD, including CD and UC, shows mixed results.74, 119, 120, 125”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [74] De Leon, 2013, Transient flare of ulcerative colitis after fecal microbiota transplantation for recurrent Clostridium difficile infection, Clin Gastroenterol Hepatol source
- Not checked yetcites [119]
- Not checked yetcites [120]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“This willingness on the part of patients to try FMT holds true regardless of their prior experience with FMT or the nature of their disease (CDI, UC or healthy patients).113–115”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [113] US Food and Drug Adminstration. FDA drug definition. FDA Glossary of terms. Available at: http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#D. Accessed May 1, 2015.
- Not checked yetcites [114] US Food and Drug Adminstration. Guidance for industry: enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. July 2013. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM361393.pdf. Accessed May 1, 2015.
- Not checked yetcites [115] Kelly, 2014, Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies, Clin Gastroenterol Hepatol source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“a survey of UC patients at a single tertiary care center showed that, despite reporting satisfactory to excellent disease control with their treatments, the vast majority were interested in, or willing to consider, FMT.114”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [114] US Food and Drug Adminstration. Guidance for industry: enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. July 2013. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM361393.pdf. Accessed May 1, 2015.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“however, the same approach in 4 patients with active UC showed no benefit.125”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [125]
plainn = 4- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“While no studies about potential barriers to the use of FMT by physicians have been published in full form”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The data regarding safety and efficacy of FMT in pediatric patients to date is quite limited.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“In Europe, the European Medicines Agency has not regulated FMT for CDI thus far.126”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [126]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“a recent abstract reporting a survey of physicians showed that 40% were not willing to try FMT, pending further demonstration of its efficacy, safety and perceived patient acceptance.116”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [116] Moore, 2014, Fecal microbiota transplantation: a practical update for the infectious disease specialist, Clin Infect Dis source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Currently, the literature is comprised of a handful of case reports and studies which include a small number of children with CDI23, 28, 97, 117 and/or IBD 67, 118, 11974, 120, 121 who were treated with FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [23] Youngster, 2014, Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection, JAMA source
- Not checked yetcites [28] Russell, 2010, Fecal bacteriotherapy for relapsing Clostridium difficile infection in a child: a proposed treatment protocol, Pediatrics source
- Not checked yetcites [97] Pathak, 2014, Treatment of relapsing Clostridium difficile infection using fecal microbiota transplantation, Clin Exp Gastroenterol
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Suskind et al. reported a clinical improvement 7 of the 9 patients with CD who received a single treatment with nasogastric FMT,74”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [74] De Leon, 2013, Transient flare of ulcerative colitis after fecal microbiota transplantation for recurrent Clostridium difficile infection, Clin Gastroenterol Hepatol source
plaindirectn = 9- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Subjects who had been hospitalized were more willing to undergo FMT (55% versus 34%, p=0.035)”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [114] US Food and Drug Adminstration. Guidance for industry: enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. July 2013. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM361393.pdf. Accessed May 1, 2015.
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“it is unknown how willing physicians in various specialties are to offer, perform, or refer patients for this treatment.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The time and administrative burden for any clinician wishing to sponsor an IND to treat his or her individual patients with FMT can be enormous.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“Though no serious short-term adverse events have been reported”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [117] Khanna S, Pardi D, Kelly C, et al. Clinical evaluation of SER-109, a rationally designed, oral microbiome-based therapeutic for the treatment of recurrent Clostridium difficile. 2014.
- Not checked yetcites [121]
- Not checked yetcites [122]
- Not checked yetcites [123]
- Not checked yetcites [124]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Worldwide, regulation of FMT varies greatly between countries.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Furthermore, it is not permissible to charge for products which are being administered under IND.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Some have even resorted to performing home-enemas of donor stool when they are unable to find a physician who is willing or able to perform FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: Some patients perform home enemas of donor stool when they cannot find a willing or able physician to perform FMT.
In the paper
“in a survey of healthy patients who were presented with hypothetical scenarios related to treatment options for recurrent CDI, 81% of patients chose FMT.113”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [113] US Food and Drug Adminstration. FDA drug definition. FDA Glossary of terms. Available at: http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#D. Accessed May 1, 2015.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
None of the sources cited for this claim have been checked yet.
In the paper
“it is premature to draw conclusions about the role of FMT in treatment of pediatric IBD.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [74] De Leon, 2013, Transient flare of ulcerative colitis after fecal microbiota transplantation for recurrent Clostridium difficile infection, Clin Gastroenterol Hepatol source
- Not checked yetcites [125]
plainn = 9- Asserted: passes — The authors put it forward as true.
- Checkable: unclear — It is unclear whether it could be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“once an IND is active, follow up documentation, such as required reporting of all serious adverse events (even if unrelated), institutional review board (IRB) oversight, safety monitoring board meetings and mandatory annual reports to the FDA are similarly time consuming and burdensome.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The enforcement discretion policy does not extend to other uses of FMT such as IBD.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Results from the phase I/II clinical trial showed 100% success at 8 weeks.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [132]
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Ser-109, a microbial product comprising a mixture of bacterial spores developed as an ecobiotic by Seres Health, demonstrated excellent efficacy in management of recurrent C. difficile diarrhea in a small open-label study.132”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [132]
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Critical methodological data such as donor/recipient screening, fecal preparation, modality of delivery, and patient consent practices are lacking.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The high therapeutic efficacy of FMT for recurrent CDI is an important proof of concept that substantial modification of the gut microbiota can be an effective modality of the treatment of a disease in humans.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Conclusions
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Rests on an assumption: FMT has high therapeutic efficacy for recurrent CDI.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The FDA announced the IND requirement in May of 2013 at a public workshop to discuss the regulatory and scientific issues around FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“The Agency agreed and subsequently stated that it would exercise “enforcement discretion” around FMT when used to by licensed physicians to treat CDI not responding to standard therapies.129”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [129]
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“Both patients improved.133”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [133]
plainn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“if fully implemented, such a policy would greatly limit FMT under the stool bank model, which uses volunteer donors who are not known to the patient or provider.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“there is very little current information about practice of FMT in the U.S.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“investigators at Queens University and Kingston General Hospital in Ontario, Canada isolated intestinal bacteria from healthy donors using modified continuous culture chemostat system.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [133]
plainn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- It may state two separate claims as one. 71
- Probably not a substantial claim. 31
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“Decrease in Lachnospiraceae has been associated with severe CDI suggesting a protective role for members of this family51”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Could not verifycites [51] Lawley, 2012, Targeted restoration of the intestinal microbiota with a simple, defined bacteriotherapy resolves relapsing Clostridium difficile disease in mice, PLoS Pathog sourceExperimental — accuracy not yet measured
The Results section on intestinal dysbiosis reports reduced microbiota diversity in mice with persistent C. difficile infection, but does not identify a decrease in Lachnospiraceae. A search for Lachnospiraceae and its proposed protective role found no passage establishing the family-specific association with severe CDI. (LLM, conf=0.75)
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Could not verify
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“FMT appears to be relatively safe in the short-term, especially when compared to its efficacy in treating recurrent CDI.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
What the sources say
- Supportedcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
The Adverse Events section reports that infusion-day symptoms resolved within three hours and that no other treatment-related adverse events were reported during follow-up. The Results section reports resolution of recurrent C. difficile infection in 13 of 16 patients after one infusion, compared with 4 of 13 and 3 of 13 in the vancomycin groups. Together, these findings support the qualified assessment of short-term safety relative to efficacy in this small trial. (LLM, conf=0.92)
- Not checked yetcites [27] MacConnachie, 2009, Faecal transplant for recurrent Clostridium difficile-associated diarrhoea: a UK case series, Q J Med
- Supportedcites [35] Mattila, 2012, Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection, Gastroenterology source
The Discussion describes fecal transplantation as a rather safe procedure and says its results appear clearly better than other treatments for recurrent CDI. The Abstract reports no immediate complications and favorable responses in most patients during the first 12 weeks, supporting the claim’s short-term qualification. (LLM, conf=0.92)
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
None of the sources cited for this claim have been checked yet.
In the paper
“Limited studies on patient perceptions regarding FMT done to date report that patients recognize the unappealing nature of FMT, yet are still open to considering it as a treatment, especially when recommended by a physician.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [113] US Food and Drug Adminstration. FDA drug definition. FDA Glossary of terms. Available at: http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#D. Accessed May 1, 2015.
- Not checked yetcites [114] US Food and Drug Adminstration. Guidance for industry: enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. July 2013. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM361393.pdf. Accessed May 1, 2015.
- Could not verifycites [115] Kelly, 2014, Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies, Clin Gastroenterol Hepatol sourceExperimental — accuracy not yet measured
The Introduction discusses FMT as a potential treatment, while “Risks Associated with FMT” addresses informed consent; neither reports patient perceptions. Searches for patients finding FMT unappealing, willingness to consider it, and physician recommendations found no supporting passage in our copy. (LLM, conf=0.76)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Though FMT appears to be safe, with few short-term adverse effects or complications directly attributed to the procedure yet reported”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Conclusions
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“It is now understood that the gut microbiota coevolved with the human host over thousands of years and are integral to overall human physiology, playing a pivotal role in metabolism, immune system function and maintenance of gut homeostasis.1, 2”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Introduction
What the sources say
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Moreover, the restoration of more typical microbial communities, which come to resemble those of the donor post-transplant, persists in a durable fashion after FMT.6, 7”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Introduction
What the sources say
- Not checked yetcites [6] Khoruts, 2010, Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea, J Clin Gastroenterol source
- Not checked yetcites [7] Hamilton, 2013, High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria, Gut Microbes source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Furthermore successful FMT restores members of Lachnospiraceae and other butyrate producing organisms supporting their potential role in outcompeting C. difficile.50”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [50] Reeves, 2012, Suppression of Clostridium difficile in the gastrointestinal tracts of germfree mice inoculated with a murine isolate from the family Lachnospiraceae, Infect Immun source
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“This study, conducted in the Netherlands, showed duodenal infusion of donor feces to effectively resolve recurrent CDI in 81% of patients treated, compared to only 31% efficacy of a standard course of oral vancomycin.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The mechanisms underlying decreased fitness of C. difficile following FMT still remain elusive but likely include niche exclusion, competition for nutrients and creation of a nutrient milieu unfavorable for growth, ability of members of healthy gut microbiota to produce antimicrobials that inhibit growth of C. difficile and an increase in secondary bile acid production.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“FMT has been examined in both young and old, patients with limited comorbidities as well as those considered to be immunocompromised,43 and the procedure has been shown to be safe, well-tolerated, and effective.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“They reported an overall 90% response rate making oral administration a viable alternative to the current practice of administering fecal material via an endoscopic procedure thus decreasing both cost and potential procedural complications.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [23] Youngster, 2014, Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection, JAMA source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“however a few case reports suggest that it may be safe and effective even in critically ill patients18–21.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Indications
What the sources say
- Not checked yetcites [18] You, 2008, Successful treatment of fulminant Clostridium difficile infection with fecal bacteriotherapy, Ann Intern Med source
- Not checked yetcites [19] Weingarden, 2013, Resolution of severe Clostridium difficile infection following sequential fecal microbiota transplantation, J Clin Gastroenterol source
- Not checked yetcites [20] Trubiano, 2013, Faecal microbiota transplantation for severe Clostridium difficile infection in the intensive care unit, Eur J Gastroenterol Hepatol source
- Not checked yetcites [21] Neemann, 2012, Fecal microbiota transplantation for fulminant Clostridium difficile infection in an allogeneic stem cell transplant patient, Transpl Infect Dis source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“In a systematic review, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema) led to the achievement of higher eradication rates than upper delivery (gastroscopy, nasogastric or nasointestinal tube) (81–86% vs 84–93%, respectively)3.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [3] Cammarota, 2014, Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review, J Clin Gastroenterol source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Furthermore, FMT appeared safe, with no serious adverse events in these subjects.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“An early study investigating the effect of antibiotics on gut microbiota function described decreased urobilinogen and fecal tryptic activity as well as decreased conversion of cholesterol to coprostanol following antibiotic treatment.25”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [25] Gustafsson, 1999, The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea, Scand J Gastroenterol source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“of the over 500 cases reported to date3, FMT has demonstrated rapid response and a cure rate of nearly 90%, with a negligible significant adverse event rate, regardless of route.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
What the sources say
- Not checked yetcites [3] Cammarota, 2014, Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review, J Clin Gastroenterol source
boosteddirectn = 500- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“though a cost-effectiveness study showed FMT dominated (i.e. was less costly and more effective) than vancomycin for initial CDI42.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Current Treatment Guidelines and Methods > Stool Preparation and Methods of Administration
What the sources say
- Not checked yetcites [42] Kelly, 2014, Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients, Am J Gastroenterol source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“FMT appears to result in durable engraftment of new species from donor as well as augmentation of species present at only very low levels prior to FMT6.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [6] Khoruts, 2010, Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea, J Clin Gastroenterol source
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“FMT represents one of the most efficacious treatments available for recurrent CDI, though the exact mechanism of effect still remains to be elucidated.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Numerous case reports, retrospective case series and a single randomized controlled trial have demonstrated benefit of FMT in patients with severe or recurrent CDI with cure rates as high as 100% and a mean cure rate of 87–90% for the over 500 cases reported in the world literature to date.3–5”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Introduction
What the sources say
- Not checked yetcites [3] Cammarota, 2014, Fecal microbiota transplantation for the treatment of Clostridium difficile infection: a systematic review, J Clin Gastroenterol source
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
- Not checked yetcites [5] Kassam, 2013, Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis, Am J Gastroenterol source
boosteddirectn = 500- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Dethlefsen et al. investigated the effect of ciprofloxacin in three individuals and found reduced microbial taxonomic diversity, richness and evenness, although the magnitude of effect differed among individuals.47”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [47] Theriot, 2014, Antibiotic-induced shifts in the mouse gut microbiome and metabolome increase susceptibility to Clostridium difficile infection, Nat Commun source
plaindirectn = 3- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Interestingly these changes were modified following fecal transplant from healthy individuals with increased appearance of coprostanol and urobilinogen.25”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Mechanisms
What the sources say
- Not checked yetcites [25] Gustafsson, 1999, The effect of faecal enema on five microflora-associated characteristics in patients with antibiotic-associated diarrhoea, Scand J Gastroenterol source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“In the study by Moayyedi et. al, seventy-five patients with active UC were randomized to a weekly FMT or water enema for 6 weeks, and there was a statistically significant difference in remission, the primary outcome, between the two groups.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [77] Rossen, 2015, Findings from a randomized controlled trial of fecal transplantation for patients with ulcerative colitis, Gastroenterology source
plaindirectn = 75- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Unfortunately, it is difficult to infer robust conclusions about the safety and efficacy of FMT for IBD from these studies because they were under-powered, open-labeled, lacked uniformity in treatment protocols and delivery approaches, and did not include control groups.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The exact mechanisms by which gut microbiota influence obesity still remain to be elucidated”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Obesity
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Preliminary case reports of FMT enemas in patients with ulcerative colitis (UC) and Crohn’s disease (CD) were promising, reporting that patients achieved clinical remission, and maintained remission over long-term follow-up in many of the cases61, 62”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“The dysbiosis is characterized by a decreased diversity at the species level, with notable decreases in the Bacteroidetes phylum and the Lachnospiraceae group within the Firmicutes phylum and increases in Proteobacteria and Actinobacteria.59”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [59] Sokol, 2008, Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients, Proc Natl Acad Sci U S A source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“IBS is a widely prevalent chronic GI disorder affecting nearly 20% of the North American population85”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [85] Matto, 2005, Composition and temporal stability of gastrointestinal microbiota in irritable bowel syndrome—a longitudinal study in IBS and control subjects, FEMS Immunol Med Microbiol source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Furthermore, flares of FMT in patients with both UC and CD have been described,43, 75, 76 raising important questions around safety and the potential to worsen disease in some patients.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
- Not checked yetcites [75] Kelly, 2014, New diagnosis of Crohn's colits 6 weeks after fecal microbiota transplantation, Inflamm Bowel Dis source
- Not checked yetcites [76] Moayyedi, 2015, Fecal microbiota transplantation induces remission in patients with active ulcerative colitis in a randomized, controlled trial, Gastroenterology source
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“is associated with significant morbidity and health care expenditure.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [85] Matto, 2005, Composition and temporal stability of gastrointestinal microbiota in irritable bowel syndrome—a longitudinal study in IBS and control subjects, FEMS Immunol Med Microbiol source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“The pooled estimates were highest in younger patients (7–20 years old) and in patients with Crohn’s disease, with 64.1% and 60.5% achieving clinical remission, respectively.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [73] Suskind, 2015, Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease, Inflamm Bowel Dis source
plaincorrelationaln = 122- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“This review also found that although FMT was not associated with any serious adverse events during short-term follow up, a number of patients experienced fever, chills, and gastrointestinal symptoms including bloating, flatulence, vomiting, diarrhea, and abdominal tenderness.73”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > FMT for Inflammatory Bowel Disease
What the sources say
- Not checked yetcites [73] Suskind, 2015, Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease, Inflamm Bowel Dis source
plaincorrelationaln = 122- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The underlying pathophysiology of symptoms in IBS is not well defined though both central and perpipheral mechanisms have been implicated.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Transmission of enteric pathogens via FMT is also an important concern but appears to be rare with current screening.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [107] Kahn, 2012, Colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection in a child, Am J Gastroenterol source
- Not checked yetcites [108] Russell, 2014, Fecal transplant for recurrent Clostridium difficile infection in children with and without inflammatory bowel disease, J Pediatr Gastroenterol Nutr source
hedgedn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“nearly 90% of patients who were treated with FMT had an improvement in defecation and decreased abdominal bloating after FMT with 60% showing long term benefit from 9–19 months.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [95] Hamilton MJ, Weingarden AR, Sadowsky MJ, et al. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol;107:761–767. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“The other died 13 days post-FMT secondary to progressive pneumonia, for which she was treated with antibiotics before and after FMT. This death was felt to be unrelated to the FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“However, changes in microbiota composition are not consistent across studies, possibly due to heterogeneous study populations and differing methodologies for sample preparation and analysis.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Irritable bowel syndrome
What the sources say
- Not checked yetcites [86] Balsari, 1982, The fecal microbial population in the irritable bowel syndrome, Microbiologica
- Not checked yetcites [87] Malinen, 2005, Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR, Am J Gastroenterol source
- Not checked yetcites [88] Simren, 2013, Intestinal microbiota in functional bowel disorders: a Rome Foundation report, Gut source
- Not checked yetcites [89] Crouzet, 2013, The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota, Neurogastroenterol Motil source
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Such risks include the possible transmission of infectious agents via FMT or development of diseases/conditions related to changes in the gut microbiota.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The influence of route of administration on development of symptoms after FMT is uncertain.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In both cases donors were asymptomatic, and testing for norovirus in one of the donors was negative.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [107] Kahn, 2012, Colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection in a child, Am J Gastroenterol source
plainn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“FMT is being actively investigated as a therapeutic strategy for many other diseases including the metabolic syndrome, Type 2 diabetes mellitus, fatty liver disease, multidrug resistant organism eradication, hepatic encephalopathy and pediatric allergy disorders.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > FMT in Diseases Other than Clostridium difficile > Other Indications
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“These symptoms, which resolved in all patients within 3 hours, were not reported in the control group receiving only bowel lavage.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
plainn = 16- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Among 16 patients receiving FMT via duodenal infusion plus bowel lavage, 15 experienced diarrhea, 5 abdominal cramps, 3 belching, and 1 nausea.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [4] Van Nood, 2013, Duodenal infusion of donor feces for recurrent Clostridium difficile, N Engl J Med source
plainn = 16- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“However, there were two deaths, one an aspiration event related to the procedure used to administer FMT and 17% of IBD patients experienced disease flare post-FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“These include complications of endoscopy, such as perforation and bleeding, and side effects related to sedation, such as aspiration43.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Short-term adverse events
What the sources say
- Not checked yetcites [43] Youngster, 2014, Fecal microbiota transplant for relapsing Clostridium difficle infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study, Clin Infect Dis source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Due to the recent emergence FMT, little data exists regarding long-term events and many are speculative.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“production of the pro-atherogenic metabolite trimethylamine-N-oxide is dependent on the gut microbiota, and increased levels of this metabolite are associated with an increase in major cardiovascular events111.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Safety of FMT > Potential Long-term adverse events
What the sources say
- Not checked yetcites [111] van Nood, 2014, Fecal microbiota transplantation: facts and controversies, Curr Opin Gastroenterol source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Patients suffering from recurrent CDI are desperate for a cure and may seek guidance from online communities.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Rests on an assumption: Patients with recurrent CDI are desperate for a cure and may seek guidance from online communities.
In the paper
“a YouTube video describing do-it-yourself FMT has been viewed over 45,000 times.112”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [112] Allen-Vercoe, 2012, A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics, Can J Gastroenterol source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“others have reported on the safety and efficacy of FMT for children with recurrent CDI without underlying IBD via nasogastric tube, colonoscopy, and capsules with a cure rate of 92% (24/26) and no serious adverse events reported.117, 121–124”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [117] Khanna S, Pardi D, Kelly C, et al. Clinical evaluation of SER-109, a rationally designed, oral microbiome-based therapeutic for the treatment of recurrent Clostridium difficile. 2014.
- Not checked yetcites [121]
- Not checked yetcites [122]
- Not checked yetcites [123]
- Not checked yetcites [124]
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The Therapeutic Goods Administration in Australia, where FMT is not considered a drug or regulated for any indication, has provided no communications regarding FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The IND process is largely tailored to the pharmaceutical industry and regulatory experts.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
In the paper
“Brandt et al surveyed the perceptions of 77 patients who had experienced recurrences of CDI and were treated with FMT; 97% reported that they would want FMT in the event of another recurrence, and 53% of them would have opted for FMT as primary treatment prior to a trial of antibiotics for their first recurrence if given the option.32”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
What the sources say
- Not checked yetcites [32] Brandt, 2012, Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection, Am J Gastroenterol source
plainn = 77- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“In children with recurrent CDI and underlying IBD, the data the data is mixed, highlighting the difficulty in distinguishing a clinical response to an infection that may have the same symptoms as the underlying disease.118, 121, 124”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [118] Petrof, 2013, Stool substitute transplant therapy for the eradication of Clostridium difficile infection: ‘RePOOPulating’ the gut, Microbiome source
- Not checked yetcites [121]
- Not checked yetcites [124]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“without large randomized controlled studies to support safety and efficacy, it is an unapproved product and an investigational new drug application (IND) is required in order to administer FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [128]
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“currently there is no data to support its use for these conditions and studies are ongoing.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“lack of adequate reimbursement for the time required by physicians may be a further deterrent.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Patient Perceptions
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Rests on an assumption: Lack of adequate reimbursement for physician time may deter FMT use.
In the paper
“the agency has maintained that, at this point, the process of donor eligibility determination and screening, stool processing and infusion defines the FMT “product” and falls under FDA jurisdiction.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [128]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Requiring physicians to hold an IND to administer FMT would prevent many from offering this therapy and ensure that only commercial entities with the means to navigate the regulatory process and fund large clinical trials will control this effective therapy.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“There has also been significant parental interest in FMT for the treatment of other childhood diseases such as food allergies, autism, and chronic diarrhea”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The case involved a 2 year old child with recalcitrant CDI that had failed an exhaustive course, including probiotics, metronidazole, pulsed-dose vancomycin, rifaximin, and nitazoxanide, who experienced complete resolution of symptoms within 36 hours of FMT.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
What the sources say
- Not checked yetcites [118] Petrof, 2013, Stool substitute transplant therapy for the eradication of Clostridium difficile infection: ‘RePOOPulating’ the gut, Microbiome source
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Though several FMT trials are ongoing in China, there has been no indication that The Ministry of Health intends to exercise authority over the procedure.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“The United States Food and Drug Administration (FDA) has determined that administered stool constitutes a biological product and a drug”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [128]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Health Canada considers FMT and related synthetic stool therapies as a “New Biologic Drug” and requires any clinical study go through the process of a clinical trial application (CTA) to ensure that quality and safety standards are met.127”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [127]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In turn, the safety of such products would be monitored by post-market surveillance registries as required by the FDA for biologics and drugs.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“A priori knowledge is not available regarding the impact of transferring these complex communities from one individual to another, although many studies in mice indicate that the composition of the gut microbiota can affect host susceptibility to diseases.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Encapsulated formulations of fecal material would help make FMT accessible to many more patients, simplify clinical trials and, if proven safe, could potentially be used earlier in the course of disease.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“national societies have attempted to provide guidance to practitioners through published guidelines and editorials16, 130, 131 but the degree of adherence to these recommendations is unknown.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [16] Bakken, 2011, Treating Clostridium difficile infection with fecal microbiota transplantation, Clin Gastroenterol Hepatol source
- Not checked yetcites [130]
- Not checked yetcites [131]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There is speculation that other conditions marked by dysbiosis can be treated with FMT in some form, though these conditions are more complex and the outcomes after microbial manipulation are unlikely to be as dramatic and predictably effective as with CDI.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Conclusions
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.
- Rests on an assumption: Other dysbiosis-associated conditions are more complex than CDI.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Furthermore, clinical trials of FMT for C. difficile do not fall under enforcement discretion and require an IND.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Frozen preparations of donor material will enable eligible patients to be treated more easily and facilitate clinical research.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Information about the effectiveness of FMT as well as both short- and long-term safety data are not systematically collected, with the only available information being case reports published in the literature.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Commercialized preparations of human stool are currently in clinical trials and it is conceivable that the FDA might cease to offer enforcement discretion entirely once one or more of these products is approved and commercially available.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The gut microbiota is a complex consortium with many components that have never been characterized.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Although the timeline for the development of these products is currently unknown, a number are in late stage development and may be available within the next few years.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Openbiome is a stool bank located in Medford, MA USA.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In the absence of other therapies FMT remains the mainstay for management of recurrent CDI not responsive to conventional therapy.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“there has been considerable interest in the development of a national FMT registry involving collaboration between national professional and advocacy societies.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The position of the FDA on this matter continues to evolve.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It is clear that the regulatory landscape will continue to evolve as microbiota-based therapeutics emerge.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it.
- Rests on an assumption: The regulatory landscape will continue to evolve as microbiota-based therapeutics emerge.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“These include full spectrum stool-based products as well as defined microbial consortia.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“They then developed a defined microbial community of 33 strains termed RePOOPulate based on antibiotic susceptibility profiles, culturability and community robustness and administered it to two patients with relapsing C. difficile diarrhea in a proof of principle study.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
What the sources say
- Not checked yetcites [133]
plaindirectn = 2- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“While the value of FMT in treating recurrent CDI is clear, its potential long-term detrimental consequences, both beneficial and detrimental, are unknown.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This policy has enabled many patients suffering from recurrent CDI to receive FMT, but is probably only temporary.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“it is very likely that whole-stool FMT, as currently practiced, is a short-term bridge for the treatment of CDI that will be replaced by commercially developed products.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds.
- Rests on an assumption: Whole-stool FMT as currently practiced will be replaced by commercially developed products.
In the paper
“the FDA will not enforce its own requirement that FMT be done under IND, as long as providers obtain informed consent, detail risks around the procedure, and explain that FMT is considered an investigational therapy.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Regulatory issues
What the sources say
- Not checked yetcites [129]
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“This non-profit organization has already supplied over 2000 doses of donor stool to over 200 institutions in the United States at a cost of around $250 USD per dose and has recently secured an IND for this product.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Such a registry would serve as a unique national resource of information about the clinical practice of FMT in the U.S.”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Future of FMT & Microbial Therapeutics
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it.
The paper relies on this without support.
Alterations in gut ecology (dysbiosis) are implicated in multiple disease states, with CDI as the prototypical example.
“Alterations of this ecology (or dysbiosis) has been implicated in a number of disease states, the prototypical example being Clostridium difficile infection (CDI).”
The paper relies on this without support.
Patients with severe CDI are at greater risk for poor outcomes.
“Certainly patients with severe CDI are at greater risk for poor outcomes and decisions to proceed with FMT, versus surgery or other standard of care modalities, should be made with caution.”
The paper relies on this without support.
C. difficile generally causes disease in people with decreased diversity of gastrointestinal microflora, typically due to antibiotic use.
“C. difficile is an opportunistic organism, which generally causes disease in persons with decreased diversity of the gastrointestinal microflora (typically as a result of antibiotic use).”
The paper relies on this without support.
Bile acid composition significantly affects C. difficile growth, with primary bile acids such as taurocholate favoring germination of C. difficile spores.
“Bile acid composition can significantly impact C. difficile growth with primary bile acids such as taurocholate favoring germination of C. difficile spores.”
The paper relies on this without support.
A lack of effective non-surgical therapies for obesity is a reason to investigate factors that contribute to obesity.
“The lack of effective, non-surgical therapies has led to investigation of potential factors contributing to the development of obesity.”
The paper relies on this without support.
Gut microbiota can ferment dietary carbohydrates and provide additional energy to the host as short-chain fatty acids.
“Gut microbiota can ferment dietary carbohydrates and provide additional energy to the host in the form of short chain fatty acids.”
The paper relies on this without support.
Patients with recurrent CDI are desperate for a cure and may seek guidance from online communities.
“Patients suffering from recurrent CDI are desperate for a cure and may seek guidance from online communities.”
The paper relies on this without support.
Many patients are willing to travel great distances to undergo FMT.
“Many are willing to travel great distances to undergo FMT.”
The paper relies on this without support.
Some patients perform home enemas of donor stool when they cannot find a willing or able physician to perform FMT.
“Some have even resorted to performing home-enemas of donor stool when they are unable to find a physician who is willing or able to perform FMT.”
The paper relies on this without support.
Lack of adequate reimbursement for physician time may deter FMT use.
“lack of adequate reimbursement for the time required by physicians may be a further deterrent.”
The paper relies on this without support.
The regulatory landscape will continue to evolve as microbiota-based therapeutics emerge.
“It is clear that the regulatory landscape will continue to evolve as microbiota-based therapeutics emerge.”
The paper relies on this without support.
Whole-stool FMT as currently practiced will be replaced by commercially developed products.
“it is very likely that whole-stool FMT, as currently practiced, is a short-term bridge for the treatment of CDI that will be replaced by commercially developed products.”
The paper relies on this without support.
FMT has high therapeutic efficacy for recurrent CDI.
“The high therapeutic efficacy of FMT for recurrent CDI is an important proof of concept”
The paper relies on this without support.
Other dysbiosis-associated conditions are more complex than CDI.
“though these conditions are more complex and the outcomes after microbial manipulation are unlikely to be as dramatic and predictably effective as with CDI”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“Unrelated FMT volunteer donors may be more beneficial in cases where genetics play a contributing factor in the disease, like IBD. 55”
From Fecal microbiota transplantation: Review and update (2019) · cites this paper as [55]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
“lower gastrointestinal route (colonoscopy, enema) led to the achievement of higher eradication rates than upper delivery (gastroscopy, nasogastric or nasointestinal tube) (81–86% vs 84–93%, respectively)3”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Efficacy data in CDI
“(81–86% vs 84–93%, respectively)”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > Pediatric Considerations
“In 2010, Russell et al. report the first pediatric patient treated with FMT via nasogastric tube.118”
§ Update on FMT 2015: Indications, Methodologies, Mechanisms and Outlook > References
“118. Russell GH Kaplan JL Youngster I Fecal transplant for recurrent Clostridium difficile infection in children with and without inflammatory bowel disease J Pediatr Gastroenterol Nutr 2014 58 588 92 24792627”
Citations
Cites
An obesity-associated gut microbiome with increased capacity for energy harvest
Turnbaugh, P. J., Ley, R. E., Mahowald, M. A., Magrini, V., Mardis, E. R., & Gordon, J. I. (2006) · Nature · doi:10.1038/nature05414 · Cited by 12,444
Changes of Intestinal Functions in Liver Cirrhosis
Fukui, H., & Wiest, R. (2016) · Inflammatory Intestinal Diseases · doi:10.1159/000444436 · Cited by 6,820
Host-Bacterial Mutualism in the Human Intestine
Bäckhed, F., Ley, R. E., Sonnenburg, J. L., Peterson, D. A., & Gordon, J. I. (2005) · Science · doi:10.1126/science.1104816 · Cited by 5,277
Frank, D. N., St. Amand, A. L., Feldman, R. A., Boedeker, E. C., Harpaz, N., & Pace, N. R. (2007) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.0706625104 · Cited by 4,611
Sokol, H., Pigneur, B., Watterlot, L., Lakhdari, O., Bermúdez-Humarán, L. G., Gratadoux, J.-J., Blugeon, S., Bridonneau, C., Furet, J.-P., Corthier, G., et al. (2008) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.0804812105 · Cited by 4,413
Gut Microbiota from Twins Discordant for Obesity Modulate Metabolism in Mice
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Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile
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Metadata
- Authors
- Kelly, C. R., Kahn, S., Kashyap, P., Laine, L., Rubin, D., Atreja, A., Moore, T., & Wu, G.
- Affiliations
- Brown University (US)
- University of Chicago (US)
- Mayo Clinic (US)
- Yale University (US)
- Icahn School of Medicine at Mount Sinai (US)
- University of Pennsylvania (US)
- Corresponding author
- Kelly, Colleen R.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2015-07
- Volume
- 149
- Issue
- 1
- Pages
- 223-237
- ISSN
- 0016-5085 (ISSN-L)
- PMC
- PMC4755303
- OpenAlex
- W1756046628
- Cited by
- 572
- References
- 118
- Citations by year
- 2026: 25 · 2025: 29 · 2024: 45 · 2023: 31 · 2022: 44 · 2021: 44 · 2020: 69 · 2019: 74 · 2018: 67 · 2017: 75 · 2016: 56 · 2015: 12
- FWCI
- 10.54
- Type
- journal article
- Language
- en
- Update notices
- erratum (2015-11-01)
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- American College of Gastroenterology
- National Institute of General Medical Sciences (R01GM103591)
- National Institute of Diabetes and Digestive and Kidney Diseases (K08DK100638, R21DK093839)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- fecal microbiota transplantation, gut microbiota, dysbiosis, Clostridium difficile infection, recurrent Clostridium difficile infection, inflammatory bowel disease, irritable bowel syndrome, metabolic syndrome
- MeSH terms
- Adult, Biological Therapy, Clostridium Infections, Feces, Female, Humans, Male, Middle Aged, Clostridioides difficile, Microbiota
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-07, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-07 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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