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A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
OpenBiome
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02847481
First received: July 12, 2016
Last updated: March 2, 2017
Last verified: March 2017
  Purpose
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.

Condition Intervention Phase
Irritable Bowel Syndrome
Procedure: fecal microbiota transplantation
Drug: placebo fecal microbiota transplantation
Procedure: FMT with antibiotic pre-treatment (v1)
Procedure: FMT with antibiotic pre-treatment (v2)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • stable engraftment of donor microbiota [ Time Frame: 10 weeks ]
    Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.


Estimated Enrollment: 80
Study Start Date: May 2016
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fecal microbiota transplantation
fecal microbiota transplantation
Procedure: fecal microbiota transplantation
fecal microbiota transplantation
Placebo Comparator: placebo fecal microbiota transplantation
placebo fecal microbiota transplantation
Drug: placebo fecal microbiota transplantation
placebo fecal microbiota transplantation
Experimental: FMT after antibiotic pretreatment v1
fecal microbiota transplantation after antibiotic pretreatment
Procedure: fecal microbiota transplantation
fecal microbiota transplantation
Procedure: FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v1)
Experimental: FMT after antibiotic pretreatment v2
fecal microbiota transplantation after antibiotic pretreatment
Procedure: fecal microbiota transplantation
fecal microbiota transplantation
Procedure: FMT with antibiotic pre-treatment (v2)
FMT with antibiotic pre-treatment (v2)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS with diarrhea
  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: NCT02847481

Contacts
Contact: Vivian Cheng 617.667.0682 vcheng2@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH    617-667-0682    vcheng2@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
OpenBiome
Investigators
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02847481     History of Changes
Other Study ID Numbers: 2015P000211
Study First Received: July 12, 2016
Last Updated: March 2, 2017

Keywords provided by Beth Israel Deaconess Medical Center:
Fecal Microbiota Transplantation

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on May 25, 2017