A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Procedure: fecal microbiota transplantation; Drug: placebo fecal microbiota transplantation; Procedure: FMT with antibiotic pre-treatment (v1); Procedure: FMT with antibiotic pre-treatment (v2)

• Registration Number: NCT02847481
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Primary Completion: 2018-08-05
• Study Completion: 2018-08-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• IBS with diarrhea

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT after antibiotic pretreatment v1	FMT with antibiotic pre-treatment (v1)	fecal microbiota transplantation after antibiotic pretreatment
fecal microbiota transplantation	fecal microbiota transplantation	fecal microbiota transplantation
placebo fecal microbiota transplantation	placebo fecal microbiota transplantation	placebo fecal microbiota transplantation
FMT after antibiotic pretreatment v1	fecal microbiota transplantation	fecal microbiota transplantation after antibiotic pretreatment
FMT after antibiotic pretreatment v2	fecal microbiota transplantation	fecal microbiota transplantation after antibiotic pretreatment
FMT after antibiotic pretreatment v2	FMT with antibiotic pre-treatment (v2)	fecal microbiota transplantation after antibiotic pretreatment

Primary Outcome Measures

Name	Time	Method
stable engraftment of donor microbiota	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States