Fecal Microbiota Transplant National Registry

NCT03325855 · tracked via the Priya Life Science Canada tracker

Sponsor

American Gastroenterological Association

Phase

Observational

Started

2017-09-20

Last updated

2026-01-21

Condition(s) studied

Fecal Microbiota TransplantationClostridium Difficile InfectionGut Microbiome

Investigational drug(s) / intervention(s)

None - Observational

None - Observational: None - Observational

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (53)

Facility	City	Region	Status
Phoenix Children's Hospital	Phoenix	Arizona	Withdrawn
Children's Hospital of Los Angeles	Los Angeles	California	Active Not Recruiting
University of California	Los Angeles	California	Withdrawn
Stanford University	Redwood City	California	Recruiting
Sutter Roseville Medical Center	Roseville	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Ventura Clinical Trials	Ventura	California	Withdrawn
Yale New Haven Hospital	Hamden	Connecticut	Recruiting
MedStar Georgetown University Hospital	Georgetown	District of Columbia	Active Not Recruiting
Best Quality Research, Inc.	Hialeah	Florida	Withdrawn
University of Miami, Miller School of Medicine	Miami	Florida	Recruiting
GI Pros	Naples	Florida	Withdrawn
Emory University School of Medicine	Atlanta	Georgia	Recruiting
The University of Chicago	Chicago	Illinois	Recruiting
University of Chicago School of Medicine	Chicago	Illinois	Active Not Recruiting
NorthShore University Health System	Evanston	Illinois	Terminated
Loyola University Medical Center	Maywood	Illinois	Active Not Recruiting
Loyola University of Chicago/ Loyola University Medical Center	Maywood	Illinois	Recruiting
Carle Foundation Hospital	Urbana	Illinois	Completed
Indiana University School of Medicine	Indianapolis	Indiana	Recruiting
University of Kansas Medical Center Research Institute	Kansas City	Kansas	Recruiting
Ochsner	New Orleans	Louisiana	Recruiting
Johns Hopkins University School of Medicine	Baltimore	Maryland	Completed
American Gastroenterological Association	Bethesda	Maryland	Active Not Recruiting
Boston Children's Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
UMass Memorial Health	Worcester	Massachusetts	Recruiting
St. Joseph Mercy Hospital	Ann Arbor	Michigan	Completed
University of Michigan	Ann Arbor	Michigan	Recruiting
Henry Ford Health Hospital	Detroit	Michigan	Recruiting
Mayo Clinic - Division of Pediatric Gastroenterology	Rochester	Minnesota	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Valley Hospital and Medical Center	Las Vegas	Nevada	Active Not Recruiting
Atlantic Health System	Morristown	New Jersey	Completed
Rutgers	New Brunswick	New Jersey	Recruiting
Penn Medicine Princeton Health	Plainsboro	New Jersey	Not Yet Recruiting
Concorde Medical Group	New York	New York	Withdrawn
New York University School of Medicine	New York	New York	Recruiting
Weill Cornell Medicine - Pediatric	New York	New York	Withdrawn
Weill Cornell Medicine	New York	New York	Recruiting

+ 13 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03325855 on ClinicalTrials.gov ↗ ← All trials in Canada