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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Olga Aroniadis, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02328547
First received: December 16, 2014
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Fecal microbiota transplantation capsules
Drug: Placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) [ Time Frame: 12 weeks ]
    IBS-SSS scores will be compared between experimental and placebo groups


Secondary Outcome Measures:
  • Change in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) [ Time Frame: baseline; day 10, week 4, week 8, week 12 (before and after cross-over) ]
    IBS-SSS scores will be compared within groups

  • Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores [ Time Frame: baseline; week 4, week 8, week 12 (before and after cross-over) ]
    IBS-QOL scores will be compared within groups

  • Change in fecal bacterial composition [ Time Frame: baseline; day 10, week 4, week 12 (before and after cross-over) ]
    fecal bacterial composition will be performed by DNA extraction, purification and amplification.

  • Number of doctors appointments or emergency room visits for treatment of uncontrolled IBS symptoms [ Time Frame: week 12 ]
  • Number of new medications initiated for treatment of uncontrolled IBS symptoms [ Time Frame: week 12 (before and after cross-over) ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: week 12 (before and after cross-over) ]

Estimated Enrollment: 110
Study Start Date: May 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fecal microbiota transplantation capsules
Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.
Other Name: FMT oral capsules
Placebo Comparator: 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.
Drug: Placebo capsules
Placebo capsules prepared by OpenBiome, Medford, MA

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02328547

Contacts
Contact: Olga C Aroniadis, MD 718-920-4846 fmtibsd@gmail.com
Contact: Lawrence J Brandt, MD 718-920-4846 lbrandt@montefiore.org

Locations
United States, Connecticut
Medical Research Center of Connecticut Recruiting
Hamden, Connecticut, United States, 06518
Contact: Candace Cotto    203-281-5112    CTFMTIBSD@gmail.com   
Contact: Paul Feuerstadt, MD    203-281-4463 ext 1016    CTFMTIBSD@gmail.com   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Olga C Aroniadis, MD    718-920-4846    fmtibsd@gmail.com   
Contact: Lawrence J Brandt, MD    718-920-4846    lbrandt@montefiore.org   
Concorde Medical Group Recruiting
New York, New York, United States, 10016
Contact: Thuy Ong    212-889-5544 ext 199    FMTstudy@concordemed.com   
Contact: Caterina Oneto, MD    212-889-5544 ext 154    FMTstudy@concordemed.com   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Olga C Aroniadis, MD Montefiore Medical Center
Principal Investigator: Lawrence J Brandt, MD Montefiore Medical Center
  More Information

Responsible Party: Olga Aroniadis, M.D., Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02328547     History of Changes
Other Study ID Numbers: MMC-FMT-IBSD
Study First Received: December 16, 2014
Last Updated: September 12, 2016

Keywords provided by Montefiore Medical Center:
fecal microbiota transplantation
diarrhea-predominant

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 28, 2017