Fecal Microbiota Transplant National Registry
- Conditions
- Fecal Microbiota TransplantationClostridium Difficile InfectionGut Microbiome
- Registration Number
- NCT03325855
- Lead Sponsor
- American Gastroenterological Association
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
-
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
- Incarceration
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
University of California
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Redwood City, California, United States
Sutter Roseville Medical Center
🇺🇸Roseville, California, United States
MedStar Georgetown University Hospital
🇺🇸Georgetown, District of Columbia, United States
Best Quality Research, Inc.
🇺🇸Hialeah, Florida, United States
GI Pros
🇺🇸Naples, Florida, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Ventura Clinical Trials
🇺🇸Ventura, California, United States
Yale New Haven Hospital
🇺🇸Hamden, Connecticut, United States
University of Miami, Miller School of Medicine
🇺🇸Miami, Florida, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago School of Medicine
🇺🇸Chicago, Illinois, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Loyola University of Chicago/ Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute
🇺🇸Kansas City, Kansas, United States
Ochsner
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
American Gastroenterological Association
🇺🇸Bethesda, Maryland, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic - Division of Pediatric Gastroenterology
🇺🇸Rochester, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Valley Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Rutgers
🇺🇸New Brunswick, New Jersey, United States
Penn Medicine Princeton Health
🇺🇸Plainsboro, New Jersey, United States
Concorde Medical Group
🇺🇸New York, New York, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Weill Cornell Medicine - Pediatric
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Gastroenterology Group of Rochester, LLP
🇺🇸Rochester, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Brown University Women's Medicine and Collaborative
🇺🇸Providence, Rhode Island, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Children's Hospital / Baylor College of Medicine
🇺🇸Houston, Texas, United States
Baylor Research Institute - Scott & White Medical Center
🇺🇸Temple, Texas, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada