Original ResearchFull Report: Clinical—Alimentary TractFindings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis
Section snippets
Ethical Issues
The ethics committee at the study center approved the protocol (Supplementary Appendix 1). All participants provided written informed consent. Monitor visits were performed to ensure that the trial was conducted and documented properly. A Data Safety Monitoring Board (DSMB) unblinded for treatment allocation monitored safety and efficacy of the trial. The study was registered on ClinicalTrials.gov (NCT01650038) and the Dutch trial registry from start of the study (NTR2862). All authors had
Recruitment
From June 24, 2011 through May 28, 2014, fifty patients were recruited. An interim analysis was performed by the DSMB when 20 patients had passed their primary end point visit. Based on an observed treatment effect of less than expected, the DSMB advised a recalculation of sample size when 36 patients had passed their primary end point visit. At the second interim analyses, the DSMB advised to stop the trial due to futility. Three months results of all included patients are presented here.
Discussion
This is the first full report on the results of a proof of concept double-blind placebo-controlled trial of the efficacy of FMT in UC. In our cohort of 48 UC patients with mild to moderately active disease, 2 duodenal infusions of feces from a healthy donor did not result in a statistically significant difference in clinical remission and endoscopic improvement. Our results show that for FMT in UC, it is clearly not “one size fits all.” However, some patients do respond well to FMT, which
Acknowledgments
ClinicalTrials.gov Number: NCT01650038.
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Conflicts of interest The authors disclose no conflicts.
Funding This work was supported by MLDS grant 2011 (WO 11-17) to Noortje G. Rossen and NWO-Spinoza grant 2008 to Willem M. de Vos.
Author names in bold designate shared co-first authorship.