Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT02328547|
Recruitment Status : Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Fecal microbiota transplantation capsules Drug: Placebo capsules||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2018|
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
- Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) [ Time Frame: 12 weeks ]IBS-SSS scores will be compared between experimental and placebo groups
- 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) ]
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 ClinicalTrials.gov identifier (NCT number): NCT02328547
|United States, Connecticut|
|Medical Research Center of Connecticut|
|Hamden, Connecticut, United States, 06518|
|United States, New York|
|Concorde Medical Group|
|New York, New York, United States, 10016|
|Montefiore Medical Center|
|The Bronx, New York, United States, 10467|
|Principal Investigator:||Olga C Aroniadis, MD||Montefiore Medical Center|
|Principal Investigator:||Lawrence J Brandt, MD||Montefiore Medical Center|