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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center

Criteria

Inclusion Criteria:

• age 19-65 years

• established diagnosis of IBS-D as determined by Rome III Criteria

• moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)

• persistent symptoms despite conventional therapy

• normal colonoscopy with biopsies in the past for work-up of IBS symptoms

• negative work-up for celiac disease either by duodenal biopsies or negative serologies

Exclusion Criteria:

• pregnancy

• nursing

• cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent

• severely immunocompromised or immunosuppressed patients (e.g., organ transplant recipients, severe neutropenia with an absolute neutrophil count of <500cells/mL, current treatment or treatment within 3 months with anti-neoplastic agents and HIV-positive patients with CD4 counts <200cells/mm^3)

• treated with any antibiotics in the 3 months prior to FMT

• GI symptoms can be explained by the presence of an underlying organic disease including, underlying inflammatory bowel disease, infectious enteritis, previously established and untreated small intestinal bacterial overgrowth or known motility disorder

• previous FMT

• severe (anaphylactic) food allergy

• unable to comply with protocol requirements

• American Society of Anesthesiologists (ASA) Physical Status classification IV and V

• acute illness or fever on the day of planned FMT will be excluded (not randomized) with the option of including that subject at a future date

• new antidepressant started or dose of antidepressant change <3 months prior to enrollment

• elevated ESR or CRP within the past 3 months

• baseline laboratory abnormalities on CBC, chemistry or liver tests

• pain score >75 on IBS-SSS