Fecal Microbiota Transplant National Registry

Last updated: January 18, 2026
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

  • University of Alberta

    Edmonton 5946768, Alberta 5883102 T6G2X8
    Canada

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix 5308655, Arizona 5551752 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

    Site Not Available

  • Sutter Roseville Medical Center

    Roseville, California 95661
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Ventura Clinical Trials

    Ventura, California 93003
    United States

    Site Not Available

  • Children's Hospital of Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • University of California

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Stanford University

    Redwood City 5386834, California 5332921 94063
    United States

    Active - Recruiting

  • Sutter Roseville Medical Center

    Roseville 5388881, California 5332921 95661
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94115
    United States

    Active - Recruiting

  • Ventura Clinical Trials

    Ventura 5405878, California 5332921 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

    Site Not Available

  • Yale New Haven Hospital

    Hamden 4835654, Connecticut 4831725 06518
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Georgetown, District of Columbia 20007
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Georgetown 4138890, District of Columbia 4138106 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

    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

  • Best Quality Research, Inc.

    Hialeah 4158476, Florida 4155751 33016
    United States

    Site Not Available

  • University of Miami, Miller School of Medicine

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • GI Pros

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta 4180439, Georgia 4197000 30307
    United States

    Active - Recruiting

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago School of Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • NorthShore University Health System

    Evanston, Illinois 60201
    United States

    Site Not Available

  • 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

    Site Not Available

  • The University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Chicago School of Medicine

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • NorthShore University Health System

    Evanston 4891382, Illinois 4896861 60201
    United States

    Terminated

  • Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Site Not Available

  • Loyola University of Chicago/ Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Active - Recruiting

  • Carle Foundation Hospital

    Urbana 4914570, Illinois 4896861 61801
    United States

    Completed

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center Research Institute

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Active - Recruiting

  • Ochsner

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Active - Recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • American Gastroenterological Association

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Completed

  • American Gastroenterological Association

    Bethesda 4348599, Maryland 4361885 20814
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • UMass Memorial Health

    Worcester 4956184, Massachusetts 6254926 01604
    United States

    Active - Recruiting

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan 48105
    United States

    Completed

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • St. Joseph's Mercy Hospital Ann Arbor

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • St. Joseph Mercy Hospital

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Completed

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Henry Ford Health Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic - Division of Pediatric Gastroenterology

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Mayo Clinic - Division of Pediatric Gastroenterology

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Valley Hospital and Medical Center

    Las Vegas, Nevada 89146
    United States

    Site Not Available

  • Valley Hospital and Medical Center

    Las Vegas 5506956, Nevada 5509151 89146
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Rutgers

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Penn Medicine Princeton Health

    Plainsboro, New Jersey 08536
    United States

    Site Not Available

  • Atlantic Health System

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Completed

  • Rutgers

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Penn Medicine Princeton Health

    Plainsboro 5102728, New Jersey 5101760 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

  • Concorde Medical Group

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • New York University School of Medicine

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Weill Cornell Medicine - Pediatric

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Gastroenterology Group of Rochester, LLP

    Rochester 5134086, New York 5128638 14618
    United States

    Completed

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Temple University

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Brown University Women's Medicine and Collaborative

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Brown University Women's Medicine and Collaborative

    Providence 5224151, Rhode Island 5224323 02904
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • 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

    Site Not Available

  • Texas Children's Hospital / Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Baylor Research Institute - Scott & White Medical Center

    Temple 4735966, Texas 4736286 76508
    United States

    Completed

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Active - Recruiting

  • The Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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