Fecal Microbiota Transplant National Registry (FMT)

January 18, 2026 updated by: American Gastroenterological Association
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2X8
        • Withdrawn
        • University of Alberta
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Withdrawn
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Active, not recruiting
        • Children's Hospital of Los Angeles
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • University of California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Irene Sonu, MD
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Roseville Medical Center
        • Principal Investigator:
          • Ronald Hsu, M.D.
        • Contact:
          • Tatiana Vidal
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Max Brondfield, MD
        • Contact:
          • Rachael Delacruz
      • Ventura, California, United States, 93003
        • Withdrawn
        • Ventura Clinical Trials
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
          • Candace Cotto, RN
        • Principal Investigator:
          • Paul Feuerstadt, MD
    • District of Columbia
      • Georgetown, District of Columbia, United States, 20007
        • Active, not recruiting
        • MedStar Georgetown University Hospital
    • Florida
      • Hialeah, Florida, United States, 33016
        • Withdrawn
        • Best Quality Research, Inc.
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami, Miller School of Medicine
        • Principal Investigator:
          • David Kerman, MD
        • Contact:
          • Priscilla De Fatima Madero
      • Naples, Florida, United States, 34102
        • Withdrawn
        • GI Pros
    • Georgia
      • Atlanta, Georgia, United States, 30307
        • Recruiting
        • Emory University School of Medicine
        • Contact:
          • Drew Siskin
        • Principal Investigator:
          • Nirja Mehta, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago
        • Contact:
          • Derrick Judkins
        • Principal Investigator:
          • Tiffany Patton, M.D.
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago School of Medicine
      • Evanston, Illinois, United States, 60201
        • Terminated
        • NorthShore University Health System
      • Maywood, Illinois, United States, 60153
        • Active, not recruiting
        • Loyola University Medical Center
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University of Chicago/ Loyola University Medical Center
        • Principal Investigator:
          • Ayokunle Abegunde, M.D.
        • Contact:
          • Dejan Micic, M.D.
      • Urbana, Illinois, United States, 61801
        • Completed
        • Carle Foundation Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Principal Investigator:
          • Monika Fischer, M.D., MSc.
        • Contact:
          • Sarah Pardue Brennan, RN CCRP
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center Research Institute
        • Contact:
          • Mollie Jackson, M.D.
        • Principal Investigator:
          • Mollie Jackson, M.D.
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner
        • Principal Investigator:
          • Arnab Ray, MD
        • Contact:
          • James Gore, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Completed
        • Johns Hopkins University School of Medicine
      • Bethesda, Maryland, United States, 20814
        • Active, not recruiting
        • American Gastroenterological Association
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Principal Investigator:
          • Stacy Kahn, M.D.
        • Contact:
          • Jenna Simes
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Jessica Allegretti, MD
        • Contact:
          • Grace Hardwick
      • Worcester, Massachusetts, United States, 01604
        • Recruiting
        • UMass Memorial Health
        • Contact:
          • Anne Foley
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Patricia Bloom, M.D.
        • Contact:
          • Max Macgregor
      • Ann Arbor, Michigan, United States, 48105
        • Completed
        • St. Joseph Mercy Hospital
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health Hospital
        • Contact:
          • El-Nachef, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Sahil Khanna, MD
        • Contact:
          • Becky Hofschulte
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Division of Pediatric Gastroenterology
        • Principal Investigator:
          • Imad Absah, MD
        • Contact:
          • Mary Manyara
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Active, not recruiting
        • Valley Hospital and Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Completed
        • Atlantic Health System
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers
        • Contact:
          • Susan Cataldo
        • Principal Investigator:
          • Lea Ann Chen, MD
      • Plainsboro, New Jersey, United States, 08536
        • Not yet recruiting
        • Penn Medicine Princeton Health
        • Contact:
          • Sheryl Smolensky
        • Principal Investigator:
          • Kevin Skole, MD
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Carl Crawford, MD
        • Contact:
          • Dominique Gay
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School Of Medicine At Mount Sinai
        • Contact:
          • Josephine Mitcham
        • Principal Investigator:
          • Ari Grinspan, MD
      • New York, New York, United States, 10016
        • Recruiting
        • New York University School of Medicine
        • Principal Investigator:
          • Jordan Axelrad, MD
        • Contact:
          • Philip Dulock
      • New York, New York, United States, 10016
        • Withdrawn
        • Concorde Medical Group
      • New York, New York, United States, 10021
        • Withdrawn
        • Weill Cornell Medicine - Pediatric
      • Rochester, New York, United States, 14618
        • Completed
        • Gastroenterology Group Of Rochester, LLP
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Ajay Gulati, M.D.
        • Contact:
          • Rachel Cooke
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Melissa Hershman, M.D.
        • Principal Investigator:
          • Melissa Hershman, M.D.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Active, not recruiting
        • Temple University
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Active, not recruiting
        • Brown University Women's Medicine and Collaborative
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Active, not recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Texas Children's Hospital / Baylor College of Medicine
      • Temple, Texas, United States, 76508
        • Completed
        • Baylor Research Institute - Scott & White Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Not yet recruiting
        • West Virginia University
        • Contact:
          • Asad Pervez, M.D.
        • Principal Investigator:
          • Asad Pervez, M.D.
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin - Madison
        • Principal Investigator:
          • Nasia Safdar, MD
        • Contact:
          • Shelly Zimbric
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • The Medical College of Wisconsin
        • Principal Investigator:
          • Daniel Stein, M.D.
        • Contact:
          • Anita Ward

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment related Adverse Events
Time Frame: over 10 Years
Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
over 10 Years
Disease Re-occurrence Following FMT
Time Frame: over 10 Years
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
over 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Gastroenterological Association

Collaborators

University of Pennsylvania
University of California, San Diego
University of Minnesota
Loyola University Chicago
OpenBiome
Commure, Inc

Investigators

  • Principal Investigator: Gary D Wu, MD, Co-Director, PennCHOP Microbiome Program
  • Principal Investigator: Colleen Kelly, MD, Brigham and Women's Hospital
  • Principal Investigator: Loren Laine, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AmericanGA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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