A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2018
CompletedDecember 23, 2019
December 1, 2019
2.3 years
July 12, 2016
December 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
fecal microbiota transplantation
EXPERIMENTALfecal microbiota transplantation
placebo fecal microbiota transplantation
PLACEBO COMPARATORplacebo fecal microbiota transplantation
FMT after antibiotic pretreatment v1
EXPERIMENTALfecal microbiota transplantation after antibiotic pretreatment
FMT after antibiotic pretreatment v2
EXPERIMENTALfecal microbiota transplantation after antibiotic pretreatment
Interventions
fecal microbiota transplantation
placebo fecal microbiota transplantation
FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v2)
Eligibility Criteria
You may qualify if:
- IBS with diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- OpenBiomecollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
PMID: 35014601DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Lembo, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
July 12, 2016
First Posted
July 28, 2016
Study Start
May 1, 2016
Primary Completion
August 5, 2018
Study Completion
August 5, 2018
Last Updated
December 23, 2019
Record last verified: 2019-12