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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02328547
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : April 20, 2018
Information provided by (Responsible Party):
Olga Aroniadis, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Fecal microbiota transplantation capsules Drug: Placebo capsules Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Actual Study Start Date : May 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02328547

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United States, Connecticut
Medical Research Center of Connecticut
Hamden, Connecticut, United States, 06518
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Concorde Medical Group
New York, New York, United States, 10016
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Olga C Aroniadis, MD Montefiore Medical Center
Principal Investigator: Lawrence J Brandt, MD Montefiore Medical Center

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Responsible Party: Olga Aroniadis, M.D., Montefiore Medical Center Identifier: NCT02328547     History of Changes
Other Study ID Numbers: 2014-3941
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Olga Aroniadis, Montefiore Medical Center:
fecal microbiota transplantation

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