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4,000 patients join landmark poop transplant safety study

NCT ID NCT03325855

Knowledge-focused Sponsor: American Gastroenterological Association Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a national registry that will follow up to 4,000 people who receive a fecal microbiota transplant (FMT) for C. diff infection or other gut conditions. Researchers will track side effects, infections, and whether the disease comes back. The goal is to better understand the long-term safety and effectiveness of this treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients receiving FMT or other gut-related-microbiota products and the donors providing specimens for the enrolled patients' FMT. Patients will be enrolled regardless of race, gender, ethnicity, or age.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Recipient Inclusion Criteria * Ability to give informed consent * Receiving FMT or other gut-related microbiota product within 90 days after providing consent * Access to internet and/or telephone * Donor Inclusion * Ability to give informed consent * Providing stool sample for FMT Exclusion Criteria: * Incarceration

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium difficile infection Fecal microbiota transplantation Gut microbiome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • American Gastroenterological Association

    ACTIVE_NOT_RECRUITING

    Bethesda, Maryland, 20814, United States

  • Atlantic Health System

    COMPLETED

    Morristown, New Jersey, 07960, United States

  • Baylor Research Institute - Scott & White Medical Center

    COMPLETED

    Temple, Texas, 76508, United States

  • Best Quality Research, Inc.

    WITHDRAWN

    Hialeah, Florida, 33016, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brown University Women's Medicine and Collaborative

    ACTIVE_NOT_RECRUITING

    Providence, Rhode Island, 02904, United States

  • Carle Foundation Hospital

    COMPLETED

    Urbana, Illinois, 61801, United States

  • Children's Hospital of Los Angeles

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90027, United States

  • Concorde Medical Group

    WITHDRAWN

    New York, New York, 10016, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30307, United States

  • GI Pros

    WITHDRAWN

    Naples, Florida, 34102, United States

  • Gastroenterology Group of Rochester, LLP

    COMPLETED

    Rochester, New York, 14618, United States

  • Henry Ford Health Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University School of Medicine

    COMPLETED

    Baltimore, Maryland, 21287, United States

  • Loyola University Medical Center

    ACTIVE_NOT_RECRUITING

    Maywood, Illinois, 60153, United States

  • Loyola University of Chicago/ Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic - Division of Pediatric Gastroenterology

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    ACTIVE_NOT_RECRUITING

    Georgetown, District of Columbia, 20007, United States

  • New York University School of Medicine

    RECRUITING

    New York, New York, 10016, United States

  • NorthShore University Health System

    TERMINATED

    Evanston, Illinois, 60201, United States

  • Ochsner

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn Medicine Princeton Health

    NOT_YET_RECRUITING

    Plainsboro, New Jersey, 08536, United States

  • Phoenix Children's Hospital

    WITHDRAWN

    Phoenix, Arizona, 85016, United States

  • Rutgers

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • St. Joseph Mercy Hospital

    COMPLETED

    Ann Arbor, Michigan, 48105, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

  • Sutter Roseville Medical Center

    RECRUITING

    Roseville, California, 95661, United States

  • Temple University

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Texas Children's Hospital / Baylor College of Medicine

    WITHDRAWN

    Houston, Texas, 77030, United States

  • The Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • The University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • UMass Memorial Health

    RECRUITING

    Worcester, Massachusetts, 01604, United States

  • University of Alberta

    WITHDRAWN

    Edmonton, Alberta, T6G2X8, Canada

  • University of California

    WITHDRAWN

    Los Angeles, California, 90095, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • University of Chicago School of Medicine

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kansas Medical Center Research Institute

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Miami, Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Wisconsin - Madison

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Valley Hospital and Medical Center

    ACTIVE_NOT_RECRUITING

    Las Vegas, Nevada, 89146, United States

  • Vanderbilt University Medical Center

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Ventura Clinical Trials

    WITHDRAWN

    Ventura, California, 93003, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • Weill Cornell Medicine - Pediatric

    WITHDRAWN

    New York, New York, 10021, United States

  • West Virginia University

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Yale New Haven Hospital

    RECRUITING

    Hamden, Connecticut, 06518, United States

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Other studies related to the condition(s) this trial covers.