Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial
Open accessAbstract
Background & aims Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.Methods We performed a parallel study of patients with active UC without infectious diarrhea. Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT (50 mL, via enema, from healthy anonymous donors; n = 38) or placebo (50 mL water enema; n = 37) once weekly for 6 weeks. Patients, clinicians, and investigators were blinded to the groups. The primary outcome was remission of UC, defined as a Mayo score ≤2 with an endoscopic Mayo score of 0, at week 7. Patients provided stool samples when the study began and during each week of FMT for microbiome analysis. The trial was stopped early for futility by the Data Monitoring and Safety Committee, but all patients already enrolled in the trial were allowed to complete the study.Results Seventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%-33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared with 6 of 34 of those with UC >1 year (P = .04, Fisher's exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo (P = .02, Mann-Whitney U test).Conclusions FMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes. ClinicalTrials.gov Number: NCT01545908.
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In two randomized controlled trials of UC patients, FMT responders showed a higher similarity to their donors than nonresponders.
“Finally, in two randomized controlled trials of UC patients, FMT responders showed a higher similarity to their donors than nonresponders. 61,62”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [62]
A second randomised controlled trial in ulcerative colitis, using weekly faecal enemas from healthy donors or placebo enemas for 6 weeks, demonstrated remission in a greater percentage of patients given FMT compared with the control group given water enema.
“A second trial, in which patients with UC were randomised to weekly faecal enemas from healthy donors or placebo enemas for 6 weeks, demonstrated remission in a greater percentage of patients given FMT compared with the control group (given water enema).77”
From The gut microbiota and host health: a new clinical frontier (2016) · cites this paper as [77]
Two randomised controlled trials of FMT in ulcerative colitis since that meta-analysis show discrepant results.
“Since that meta-analysis, two randomised controlled trials in UC show discrepant results.”
From The gut microbiota and host health: a new clinical frontier (2016) · cites this paper as [77]
Flares of FMT in patients with both UC and Crohn's disease have been described, raising questions about safety and potential to worsen disease in some patients.
“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.”
From Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook (2015) · cites this paper as [76]
Fecal microbiota transplantation from healthy hosts is positively correlated with disease reversal, especially those stemming from gut barrier dysfunction like IBD, IBS, celiac disease, and Clostridium difficile infections.
“Studies have revealed that fecal microbiota transplantation (FMT) from healthy hosts are positively correlated with disease reversal, especially those stemming from gut barrier dysfunction like IBD, IBS, celiac disease, and Clostridium difficile infections.19,20”
From Regulation of Intestinal Barrier Function by Microbial Metabolites (2021) · cites this paper as [19]
Randomized controlled studies have indicated that FMT appears to be somewhat effective in the treatment of UC.
“Randomized controlled studies have indicated that FMT appears to be somewhat effective in the treatment of UC (143, 144).”
From Stress triggers flare of inflammatory bowel disease in children and adults (2019) · cites this paper as [143]
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- Authors
- Moayyedi, P., Surette, M. G., Kim, P. T., Libertucci, J., Wolfe, M., Onischi, C., Armstrong, D., Marshall, J. K., Kassam, Z., Reinisch, W., & Lee, C. H.
- Affiliations
- McMaster University (CA)
- University of Guelph (CA)
- Massachusetts Institute of Technology (US)
- Corresponding author
- Moayyedi, Paul
- Lee, Christine H.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2015-07
- Volume
- 149
- Issue
- 1
- Pages
- 102-109.e6
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2078754045
- Cited by
- 1,499
- References
- 35
- Citations by year
- 2026: 62 · 2025: 111 · 2024: 121 · 2023: 129 · 2022: 143 · 2021: 155 · 2020: 180 · 2019: 162 · 2018: 127 · 2017: 152 · 2016: 115 · 2015: 38 · 2014: 1
- FWCI
- 98.98
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Crohn's and Colitis Canada
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Epidemiology › Microscopic Colitis
- Keywords
- fecal microbiota transplantation, ulcerative colitis, remission induction, enema, microbial diversity, inflammatory bowel disease, adverse events
- MeSH terms
- Adult, Aged, Biological Therapy, Colitis, Ulcerative, Feces, Female, Humans, Male, Middle Aged, Remission Induction, Microbiota
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