Irritable Bowel Syndrome Clinical Trial
Official title:
Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
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.
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.
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