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NCT02847481 Clinical Trial

A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

Irritable Bowel Syndrome Clinical Trial

Official title:
A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02847481
Other study ID # 2015P000211
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2016
Est. completion date August 5, 2018

Study information
Verified date December 2019
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 5, 2018
Est. primary completion date August 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS with diarrhea

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• fecal microbiota transplantation
fecal microbiota transplantation
Drug:
• placebo fecal microbiota transplantation
placebo fecal microbiota transplantation
Procedure:
• FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v1)
• FMT with antibiotic pre-treatment (v2)
FMT with antibiotic pre-treatment (v2)

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center OpenBiome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary stable engraftment of donor microbiota 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. 10 weeks
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