Original ResearchFull Report: Clinical—Alimentary TractFecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial
Section snippets
Study Design
This is a double-blind randomized controlled trial of FMT vs placebo in active UC conducted in Hamilton Health Sciences, St Joseph’s Healthcare Hamilton, and McMaster University, Hamilton, Canada. The local research ethics committee at McMaster University approved the trial and Health Canada had no objection to the use of FMT for this study. All participants provided written informed consent and an independent Data Monitoring and Safety Committee evaluated the trial annually.
Study Population
Eligible patients
Patients and Termination of the Trial
Patients were recruited during an 18-month period commencing in July 2012. The Data Monitoring and Safety Committee reviewed the data at the approximate 50% recruitment point of the trial and, at that time, there were 4 of 27 patients in remission in the FMT arm and 2 of 26 in the placebo arm. The Data Monitoring and Safety Committee advised that the trial should be discontinued for futility because the primary end point was unlikely to be achieved as specified in the protocol. They also
Discussion
This is the first randomized, placebo-controlled trial, to evaluate the efficacy of FMT in active UC and suggests that this approach induces remission in a statistically significant proportion of cases. FMT may be more efficacious in patients with a recent diagnosis of UC, and this is biologically plausible, as a perturbation in the microbiome might be more easily restored early in the course of the disease. The efficacy of this approach may also be donor dependent and this may explain why some
Acknowledgments
This trial was supported by grants from Hamilton Academic Health Sciences Organization (HAHSO) and Crohn’s and Colitis Canada (CCC). The authors are grateful to Lisa Dunlop and Rita Taraschi for clerical support of the trial and to Dr Ken Croitoru (chair), Josh Neufeld, and Noori Akhtar-Danesh for the services as the Data Monitoring and Safety Committee.
Author contributions: All authors contributed to the design of the study. PM and MW were responsible for the recruitment and assessment of most
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Conflicts of interest These authors disclose the following: Dr Moayyedi: Chair partly funded by an unrestricted donation given to McMaster University by AstraZeneca; received honoraria for speaking and/or serving on the advisory board for AstraZeneca, Actavis, and Shire Pharmaceuticals. Dr Marshall served as a speaker and/or served on the advisory board for Abbott/Abbvie, Actavis, Aptalis, Ferring, Janssen, Proctor & Gamble, Shire, and Takeda. Dr Reinisch served as a speaker and/or served on the advisory board for Abbott Laboratories, Abbvie, Aesca, Amgen, AM Pharma, Aptalis, Astellas, Astra Zeneca, Avaxia, Bioclinica, Biogen IDEC, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Robarts Clinical Trial, Schering-Plough, Setpointmedical, Shire, Takeda, Therakos, Tigenix, UCB, Vifor, Yakult, Zyngenia, and 4SC. Dr Armstrong has received speakers’ fees, consulting fees, research funding, or unrestricted support for educational events from Abbott, Abbvie, Actavis, Aptalis, AstraZeneca, Cook, Cubist, Ferring, Forest, Janssen, Merck, Olympus, Pendopharm, Pentax, Shire, Takeda. and Warner-Chilcott. Dr Kassam was Chief Medical Officer for OpenBiome (after trial was completed). Dr Lee served as a speaker and/or served on the advisory board for Cubist, Merck, and Rebiotix. The remaining authors disclose no conflicts.
Funding This work was funded by Hamilton Academic Health Sciences Organization (HAHSO) and Crohn’s and Colitis Canada (CCC).