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Cited by 922Inflammatory Bowel DiseaseGut microbiota and healthMicroscopic Colitis

The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.

Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis

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Rossen, Noortje G., Fuentes, Susana, van der Spek, Mirjam J., Tijssen, Jan G., Hartman, Jorn H.A., Duflou, Ann, Löwenberg, Mark, van den Brink, Gijs R., Mathus-Vliegen, Elisabeth M.H., de Vos, Willem M., Zoetendal, Erwin G., D’Haens, Geert R., Ponsioen, Cyriel Y.·2015·Gastroenterology
DOI 10.1053/j.gastro.2015.03.045
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Abstract

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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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)
DOI
10.1053/j.gastro.2015.03.045
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
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
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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