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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02328547

Run by

Montefiore Medical Center

People needed

48

Starts

2015-05-01

Expected to finish

2018-03-01

Last updated by the study team

2019-07-02

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Research Center of Connecticut — Hamden, Connecticut, United States
• Concorde Medical Group — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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