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A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

NCT02847481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-12-23

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

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)

PROCEDURE

FMT with antibiotic pre-treatment (v2)

FMT with antibiotic pre-treatment (v2)

Sponsors & Collaborators

Principal Investigators

  • Anthony Lembo, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-08-05
Completion
2018-08-05

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02847481 on ClinicalTrials.gov