Clinical trial Recruiting at 26 sites Observational

National registry for fecal microbiota transplantation

Official title: Fecal Microbiota Transplant National Registry

Run by American Gastroenterological Association · NCT03325855 · Data updated 2026-11-12

This study is collecting information from 4,000 patients who are getting fecal microbiota transplants to see how well the treatment works and what effects it has over time.

More Gut Microbiome trials

Quick facts

Study typeObservational
SexAll
Enrollment4000 (estimated)
SponsorAmerican Gastroenterological Association
Academic / other
Locations53 sites (Phoenix, Arizona and 52 other locations)
StatusRecruiting
StartedSeptember 20, 2017
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedJanuary 21, 2026
Trial IDNCT03325855 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals who are receiving fecal microbiota transplantation or other gut-related microbiota products and can provide informed consent.

Probably not a fit

Patients who are incarcerated will not be eligible for this study and therefore may not benefit from its findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to enroll 4,000 patients undergoing fecal microbiota transplantation (FMT) across 75 sites in North America. It will collect detailed information on FMT methodologies, recipient characteristics, and indications for FMT. Patients will be followed for up to 10 years post-procedure, with regular assessments of safety and effectiveness conducted through healthcare provider follow-ups and direct patient communication. The goal is to gather comprehensive data to better understand the short and long-term outcomes of FMT.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of fecal microbiota transplantation for patients with Clostridium difficile infection and other gut-related issues.

How similar studies have gone: Other studies on fecal microbiota transplantation have shown promising results, indicating that this approach is gaining traction and is supported by previous findings.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Stanford University
    Redwood City, California, United States
    Recruiting
  • Sutter Roseville Medical Center
    Roseville, California, United States
    Recruiting
  • University of California San Francisco
    San Francisco, California, United States
    Recruiting
  • Yale New Haven Hospital
    Hamden, Connecticut, United States
    Recruiting
  • University of Miami, Miller School of Medicine
    Miami, Florida, United States
    Recruiting
  • Emory University School of Medicine
    Atlanta, Georgia, United States
    Recruiting
Show 44 more locations
  • The University of Chicago
    Chicago, Illinois, United States
    Recruiting
  • Loyola University of Chicago/ Loyola University Medical Center
    Maywood, Illinois, United States
    Recruiting
  • Indiana University School of Medicine
    Indianapolis, Indiana, United States
    Recruiting
  • University of Kansas Medical Center Research Institute
    Kansas City, Kansas, United States
    Recruiting
  • Ochsner
    New Orleans, Louisiana, United States
    Recruiting
  • Boston Children's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • UMass Memorial Health
    Worcester, Massachusetts, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting
  • Henry Ford Health Hospital
    Detroit, Michigan, United States
    Recruiting
  • Mayo Clinic - Division of Pediatric Gastroenterology
    Rochester, Minnesota, United States
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting
  • Rutgers
    New Brunswick, New Jersey, United States
    Recruiting
  • New York University School of Medicine
    New York, New York, United States
    Recruiting
  • Weill Cornell Medicine
    New York, New York, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States
    Recruiting
  • University of North Carolina
    Chapel Hill, North Carolina, United States
    Recruiting
  • Oregon Health & Science University
    Portland, Oregon, United States
    Recruiting
  • University of Wisconsin - Madison
    Madison, Wisconsin, United States
    Recruiting
  • The Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting
  • Phoenix Children's Hospital
    Phoenix, Arizona, United States
    Withdrawn
  • Children's Hospital of Los Angeles
    Los Angeles, California, United States
    Active not recruiting
  • University of California
    Los Angeles, California, United States
    Withdrawn
  • Ventura Clinical Trials
    Ventura, California, United States
    Withdrawn
  • MedStar Georgetown University Hospital
    Georgetown, District of Columbia, United States
    Active not recruiting
  • Best Quality Research, Inc.
    Hialeah, Florida, United States
    Withdrawn
  • GI Pros
    Naples, Florida, United States
    Withdrawn
  • University of Chicago School of Medicine
    Chicago, Illinois, United States
    Active not recruiting
  • NorthShore University Health System
    Evanston, Illinois, United States
    Terminated
  • Loyola University Medical Center
    Maywood, Illinois, United States
    Active not recruiting
  • Carle Foundation Hospital
    Urbana, Illinois, United States
    Completed
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States
    Completed
  • American Gastroenterological Association
    Bethesda, Maryland, United States
    Active not recruiting
  • St. Joseph Mercy Hospital
    Ann Arbor, Michigan, United States
    Completed
  • Valley Hospital and Medical Center
    Las Vegas, Nevada, United States
    Active not recruiting
  • Atlantic Health System
    Morristown, New Jersey, United States
    Completed
  • Penn Medicine Princeton Health
    Plainsboro, New Jersey, United States
    Not yet recruiting
  • Concorde Medical Group
    New York, New York, United States
    Withdrawn
  • Weill Cornell Medicine - Pediatric
    New York, New York, United States
    Withdrawn
  • Gastroenterology Group of Rochester, LLP
    Rochester, New York, United States
    Completed
  • Temple University
    Philadelphia, Pennsylvania, United States
    Active not recruiting
  • Brown University Women's Medicine and Collaborative
    Providence, Rhode Island, United States
    Active not recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Active not recruiting
  • Texas Children's Hospital / Baylor College of Medicine
    Houston, Texas, United States
    Withdrawn

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Gary D Wu, MD — Co-Director, PennCHOP Microbiome Program
  • Study coordinator: Sonya Serra, MSc
  • Email: sserra@gastro.org
  • Phone: 3019412616

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.