Fecal Microbiota Transplant National Registry

Last updated: January 27, 2025
Sponsor: American Gastroenterological Association
Overall Status: Active - Recruiting

Phase

N/A

Condition

Clostridium Difficile-associated Diarrhea

Gastroenteritis

Treatment

None - Observational

Clinical Study ID

NCT03325855
AmericanGA
  • All Genders

Study Summary

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recipient Inclusion Criteria

  • Ability to give informed consent

  • Receiving FMT or other gut-related microbiota product within 90 days afterproviding consent

  • Access to internet and/or telephone

  • Donor Inclusion

  • Ability to give informed consent

  • Providing stool sample for FMT

Exclusion

Exclusion Criteria:

  • Incarceration

Study Design

Total Participants: 4000
Treatment Group(s): 1
Primary Treatment: None - Observational
Phase:
Study Start date:
September 20, 2017
Estimated Completion Date:
August 31, 2027

Study Description

This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G2X8
    Canada

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • University of California

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Sutter Roseville Medical Center

    Roseville, California 95661
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Ventura Clinical Trials

    Ventura, California 93003
    United States

    Site Not Available

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale New Haven Hospital

    Hamden, Connecticut 06518
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Georgetown, District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Best Quality Research, Inc.

    Hialeah, Florida 33016
    United States

    Site Not Available

  • University of Miami, Miller School of Medicine

    Miami, Florida 33136
    United States

    Active - Recruiting

  • GI Pros

    Naples, Florida 34102
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago School of Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • NorthShore University Health System

    Evanston, Illinois 60201
    United States

    Terminated

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Loyola University of Chicago/ Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Active - Recruiting

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Completed

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Ochsner

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Completed

  • American Gastroenterological Association

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan 48105
    United States

    Completed

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • St. Joseph's Mercy Hospital Ann Arbor

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic - Division of Pediatric Gastroenterology

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Valley Hospital and Medical Center

    Las Vegas, Nevada 89146
    United States

    Active - Recruiting

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Rutgers

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Penn Medicine Princeton Health

    Plainsboro, New Jersey 08536
    United States

    Site Not Available

  • Concorde Medical Group

    New York, New York 10016
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • New York University School of Medicine

    New York, New York 10016
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • Weill Cornell Medicine - Pediatric

    New York, New York 10021
    United States

    Site Not Available

  • Gastroenterology Group of Rochester, LLP

    Rochester, New York 14618
    United States

    Completed

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Brown University Women's Medicine and Collaborative

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Texas Children's Hospital / Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Research Institute - Scott & White Medical Center

    Temple, Texas 76508
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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