Conditions: Irritable Bowel Syndrome
Keywords: fecal microbiota transplantation diarrhea-predominant
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: no

Brief 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.

Detailed description:
This is a multicenter study including Montefiore Medical Center, Concorde Medical Group PLLC and the Medical Research Center of Connecticut/Yale-New Haven Hospital Langone Medical Center. Patients with IBS-D will be recruited from outpatient gastroenterology clinics at these institutions and referrals from the medical community.

FMT capsules and placebo capsules, provided by OpenBiome, Medford, MA, will be used for this study. Patients will be randomized to undergo FMT using fecal capsules (experimental group) or placebo capsules (control group) via a computer-generated program. All patients will cross-over into the alternate arm of the study at 12 weeks. Therefore, all patients enrolled will receive the experimental drug during the course of the study. Each patient will be enrolled in the study for a total of 6 months.

Intestinal microbiome analyses using DNA sequencing and non-cultivation-based approaches (16S DNA technology) will be performed in all patients in the experimental and control groups to assess stability of the microbiome over time.

Arms:
arm 1: Intervention: Fecal microbiota transplantation capsules containing extensively screened donor stool, prepared by OpenBiome, Medford, MA. 25 FMT capsules will be take on three consecutive days. arm 2: Intervention: Placebo capsules that do not contain donor stool or any active drug, prepared by OpenBiome, Medford, MA. 25 placebo capsules will be taken on three consecutive days.

Interventions: intervention 1: Fecal microbiota transplantation capsules intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA. intervention 2: Placebo capsules prepared by OpenBiome, Medford, MA

Protocol document:
Prot_SAP_000.pdf: 
Official Study Title: 
NCT Number: 
Document Description: 
Document Date: 
+#3H@•#il§i IRB NUMBER: 2014-3941
-.!-:,':':,.-..- IRB APPROVAL DATE: 04/24/2015 
Montefiore Medical Center 
Multicenter, Randomized, Double-blinded, Placebo-controlled Trial 
of Fecal Microbiota Transplantation (FMT) for Diarrhea-
Predominant Irritable Bowel Svndrome (IBS-D) 
NCT02328547 
Final Study Protocol with Statistical Analysis Plan (SAP) 
24 April 2015