A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
December 20, 2019 updated by: Anthony Lembo, Beth Israel Deaconess Medical Center
A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IBS with diarrhea
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fecal microbiota transplantation
|
fecal microbiota transplantation
|
|
Placebo Comparator: placebo fecal microbiota transplantation
|
placebo fecal microbiota transplantation
|
|
Experimental: FMT after antibiotic pretreatment v1
fecal microbiota transplantation after antibiotic pretreatment
|
fecal microbiota transplantation
FMT with antibiotic pre-treatment (v1)
|
|
Experimental: FMT after antibiotic pretreatment v2
fecal microbiota transplantation after antibiotic pretreatment
|
fecal microbiota transplantation
FMT with antibiotic pre-treatment (v2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anthony Lembo, MD, Beth Israel Deaconess Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
August 5, 2018
Study Completion (Actual)
August 5, 2018
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimate)
July 28, 2016
Study Record Updates
Last Update Posted (Actual)
December 23, 2019
Last Update Submitted That Met QC Criteria
December 20, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.