drugset / Trial / NCT02328547

Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome

NCT02328547

Phase 2 Completed 48 enrolled Montefiore Medical Center
RandomizedCrossoverQuadruple-blindTreatment

Summary

The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.

Timeline

Start
2015-05
Primary completion
2017-10
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ornidazole Other / unclassified 25 unknown Oral