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Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis
Open accessAbstract
Background & aims Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial.Methods Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples.Results Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point (P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point (P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa.Conclusions In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038.
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“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 [61]
In the citing paper
“One trial, in which two faecal transplants were given via the upper GI route, showed no difference in clinical or endoscopic remission between the faecal transplant group and the control group (given autologous stool).76”
From The gut microbiota and host health: a new clinical frontier (2016) · cites this paper as [76]
In the citing paper
“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 [76]
In the citing 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.”
From Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook (2015) · cites this paper as [77]
In the citing 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.”
From Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook (2015) · cites this paper as [77]
In the citing paper
“However, some researchers did not find significant differences in the efficacy of FMT, which may be related to the number and cycle of enemas, preparation process, and limited numbers (147, 148).”
From Stress triggers flare of inflammatory bowel disease in children and adults (2019) · cites this paper as [148]
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“76 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).”
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Metadata
- Authors
- Rossen, N. G., Fuentes, S., van der Spek, M. J., Tijssen, J. G., Hartman, J. H. A., Duflou, A., Löwenberg, M., van den Brink, G. R., Mathus-Vliegen, E. M. H., de Vos, W. M., Zoetendal, E. G., D’Haens, G. R., & Ponsioen, C. Y.
- Affiliations
- Amsterdam UMC Location University of Amsterdam (NL)
- Wageningen University & Research (NL)
- Corresponding author
- Ponsioen, Cyriel Y.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2015-07
- Volume
- 149
- Issue
- 1
- Pages
- 110-118.e4
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W1994882377
- Cited by
- 921
- References
- 29
- Citations by year
- 2026: 30 · 2025: 45 · 2024: 64 · 2023: 69 · 2022: 86 · 2021: 93 · 2020: 128 · 2019: 113 · 2018: 84 · 2017: 87 · 2016: 83 · 2015: 36
- FWCI
- 66.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- Socio-Environmental Systems Modeling (acceptedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek
- Topics
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Microscopic Colitis
- Keywords
- fecal microbiota transplantation, ulcerative colitis, clinical remission, endoscopic remission, Clostridium cluster XIVa, Clostridium cluster IV, gut microbiota composition, adverse events
- MeSH terms
- Adult, Aged, Biological Therapy, Colitis, Ulcerative, Double-Blind Method, Feces, Female, Humans, Intubation, Gastrointestinal, Male, Middle Aged, Remission Induction, Treatment Outcome, Microbiota
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