National registry for fecal microbiota transplantation
Fecal Microbiota Transplant National Registry
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Sex | All |
| Sponsor | American Gastroenterological Association Academic / other |
| Locations | 53 sites (Phoenix, Arizona and 52 other locations) |
| Trial ID | NCT03325855 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals who are receiving fecal microbiota transplantation or other gut-related microbiota products and can provide informed consent.
Not a fit: Patients who are incarcerated will not be eligible for this study and therefore may not benefit from its findings.
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 performed: Other studies on fecal microbiota transplantation have shown promising results, indicating that this approach is gaining traction and is supported by previous findings.
Eligibility criteria
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 this trial is running
Phoenix, Arizona and 52 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Withdrawn)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)
- 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)
- Ventura Clinical Trials — Ventura, California, United States (Withdrawn)
- Yale New Haven Hospital — Hamden, Connecticut, United States (Recruiting)
- MedStar Georgetown University Hospital — Georgetown, District of Columbia, United States (Active_not_recruiting)
- Best Quality Research, Inc. — Hialeah, Florida, United States (Withdrawn)
- University of Miami, Miller School of Medicine — Miami, Florida, United States (Recruiting)
- GI Pros — Naples, Florida, United States (Withdrawn)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
- 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)
- Loyola University of Chicago/ Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
- Carle Foundation Hospital — Urbana, Illinois, United States (Completed)
- 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)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Completed)
- American Gastroenterological Association — Bethesda, Maryland, United States (Active_not_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)
- St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States (Completed)
- 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)
- Valley Hospital and Medical Center — Las Vegas, Nevada, United States (Active_not_recruiting)
- Atlantic Health System — Morristown, New Jersey, United States (Completed)
- Rutgers — New Brunswick, New Jersey, United States (Recruiting)
- Penn Medicine Princeton Health — Plainsboro, New Jersey, United States (Not_yet_recruiting)
- Concorde Medical Group — New York, New York, United States (Withdrawn)
- New York University School of Medicine — New York, New York, United States (Recruiting)
- Weill Cornell Medicine - Pediatric — New York, New York, United States (Withdrawn)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Gastroenterology Group of Rochester, LLP — Rochester, New York, United States (Completed)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- 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)
- Baylor Research Institute - Scott & White Medical Center — Temple, Texas, United States (Completed)
- West Virginia University — Morgantown, West Virginia, United States (Not_yet_recruiting)
+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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.