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

NCT02328547 | Completed Phase 2 Results DMC

• 1 other identifier: 2014-3941
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Irritable Bowel Syndrome

Keywords

fecal microbiota transplantation; diarrhea-predominant

Outcome Measures

Primary Outcomes (1)

• Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)

  Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (\>300) irritable bowel syndrome (IBS) based on symptomology. Only the following time points were analyzed: Baseline vs Week 12 and Week 24.

  Baseline, Week 12 (before cross-over), Week 24

Secondary Outcomes (15)

• Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score

  Baseline, Week 12 (before cross-over), Week 24

• Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)

  Baseline, Week 1, Week 4 and Week 12

• Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)

  Baseline, Week 12 (before cross-over), Week 24

• Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)

  Baseline, Week 12 (before cross-over), Week 24

• Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)

  Baseline, Week 12 (before cross-over), Week 24

Study Arms (2)

FMT capsules

EXPERIMENTAL

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.

Drug: Fecal microbiota transplantation capsules

Placebo capsules

PLACEBO COMPARATOR

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.

Drug: Placebo capsules

Interventions

Fecal microbiota transplantation capsules DRUG

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

Also known as: FMT oral capsules

FMT capsules

Placebo capsules DRUG

Placebo capsules prepared by OpenBiome, Medford, MA

Placebo capsules

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (3)

Medical Research Center of Connecticut

Hamden, Connecticut, 06518, United States

Location

Concorde Medical Group

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 31326345 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Olga C. Aroniadis, PI
• Organization: Montefiore Medical Center

oaroniad@montefiore.org

718-920-4846

Study Officials

• Olga C Aroniadis, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Lawrence J Brandt, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 31, 2014
• Study Start: May 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (3)