A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

NCT ID: NCT02847481

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Fecal Microbiota Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fecal microbiota transplantation

fecal microbiota transplantation

Group Type EXPERIMENTAL

fecal microbiota transplantation

Intervention Type PROCEDURE

fecal microbiota transplantation

placebo fecal microbiota transplantation

placebo fecal microbiota transplantation

Group Type PLACEBO_COMPARATOR

placebo fecal microbiota transplantation

Intervention Type DRUG

placebo fecal microbiota transplantation

FMT after antibiotic pretreatment v1

fecal microbiota transplantation after antibiotic pretreatment

Group Type EXPERIMENTAL

fecal microbiota transplantation

Intervention Type PROCEDURE

fecal microbiota transplantation

FMT with antibiotic pre-treatment (v1)

Intervention Type PROCEDURE

FMT with antibiotic pre-treatment (v1)

FMT after antibiotic pretreatment v2

fecal microbiota transplantation after antibiotic pretreatment

Group Type EXPERIMENTAL

fecal microbiota transplantation

Intervention Type PROCEDURE

fecal microbiota transplantation

FMT with antibiotic pre-treatment (v2)

Intervention Type PROCEDURE

FMT with antibiotic pre-treatment (v2)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fecal microbiota transplantation

fecal microbiota transplantation

Intervention Type PROCEDURE

placebo fecal microbiota transplantation

placebo fecal microbiota transplantation

Intervention Type DRUG

FMT with antibiotic pre-treatment (v1)

FMT with antibiotic pre-treatment (v1)

Intervention Type PROCEDURE

FMT with antibiotic pre-treatment (v2)

FMT with antibiotic pre-treatment (v2)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* IBS with diarrhea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

OpenBiome

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anthony Lembo

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anthony Lembo, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35014601 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015P000211

Identifier Type: -

Identifier Source: org_study_id