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

NCT ID: NCT02328547

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-03-31

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FMT capsules

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation capsules

Intervention Type: DRUG

Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.

Placebo capsules

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.

Group Type: PLACEBO_COMPARATOR

Placebo capsules

Intervention Type: DRUG

Placebo capsules prepared by OpenBiome, Medford, MA

Interventions

Fecal microbiota transplantation capsules

Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.

Intervention Type: DRUG

Placebo capsules

Placebo capsules prepared by OpenBiome, Medford, MA

Intervention Type: DRUG

Other Intervention Names

FMT oral capsules

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Olga Aroniadis

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga C Aroniadis, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Lawrence J Brandt, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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

Countries

United States

References

Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17.

Reference Type: DERIVED

PMID: 31326345 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-3941

Identifier Type: -

Identifier Source: org_study_id