A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- stable engraftment of donor microbiota
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IBS with diarrhea
Exclusion Criteria
- Not provided
Arms & Interventions
FMT after antibiotic pretreatment v1
fecal microbiota transplantation after antibiotic pretreatment
Intervention: fecal microbiota transplantation (Procedure)
fecal microbiota transplantation
fecal microbiota transplantation
Intervention: fecal microbiota transplantation (Procedure)
placebo fecal microbiota transplantation
placebo fecal microbiota transplantation
Intervention: placebo fecal microbiota transplantation (Drug)
FMT after antibiotic pretreatment v1
fecal microbiota transplantation after antibiotic pretreatment
Intervention: FMT with antibiotic pre-treatment (v1) (Procedure)
FMT after antibiotic pretreatment v2
fecal microbiota transplantation after antibiotic pretreatment
Intervention: fecal microbiota transplantation (Procedure)
FMT after antibiotic pretreatment v2
fecal microbiota transplantation after antibiotic pretreatment
Intervention: FMT with antibiotic pre-treatment (v2) (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anthony Lembo
Associate Professor of Medicine
Beth Israel Deaconess Medical Center