Fecal Microbiota Transplant National Registry
FMT
1 other identifier
observational
4,000
2 countries
53
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2017
CompletedFirst Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
January 21, 2026
January 1, 2026
9.9 years
October 17, 2017
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of treatment related Adverse Events
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
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
over 10 Years
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
- Ability to give informed consent
- Providing stool sample for FMT
You may not qualify if:
- Incarceration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvaniacollaborator
- American Gastroenterological Associationlead
- OpenBiomecollaborator
- University of California, San Diegocollaborator
- University of Minnesotacollaborator
- Loyola University Chicagocollaborator
- Commure, Inccollaborator
Study Sites (53)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California
Los Angeles, California, 90095, United States
Stanford University
Redwood City, California, 94063, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
University of California San Francisco
San Francisco, California, 94115, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Yale New Haven Hospital
Hamden, Connecticut, 06518, United States
MedStar Georgetown University Hospital
Georgetown, District of Columbia, 20007, United States
Best Quality Research, Inc.
Hialeah, Florida, 33016, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
GI Pros
Naples, Florida, 34102, United States
Emory University School of Medicine
Atlanta, Georgia, 30307, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University of Chicago School of Medicine
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Loyola University of Chicago/ Loyola University Medical Center
Maywood, Illinois, 60153, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160, United States
Ochsner
New Orleans, Louisiana, 70121, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
American Gastroenterological Association
Bethesda, Maryland, 20814, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
UMass Memorial Health
Worcester, Massachusetts, 01604, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48105, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic - Division of Pediatric Gastroenterology
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Valley Hospital and Medical Center
Las Vegas, Nevada, 89146, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
Rutgers
New Brunswick, New Jersey, 08901, United States
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536, United States
Concorde Medical Group
New York, New York, 10016, United States
New York University School of Medicine
New York, New York, 10016, United States
Weill Cornell Medicine - Pediatric
New York, New York, 10021, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Gastroenterology Group of Rochester, LLP
Rochester, New York, 14618, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Brown University Women's Medicine and Collaborative
Providence, Rhode Island, 02904, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030, United States
Baylor Research Institute - Scott & White Medical Center
Temple, Texas, 76508, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of Alberta
Edmonton, Alberta, T6G2X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 30, 2017
Study Start
September 20, 2017
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01