Fecal Microbiota Transplant National Registry
Purpose
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
Conditions
- Fecal Microbiota Transplantation
- Clostridium Difficile Infection
- Gut Microbiome
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
Redwood City 5386834, California 5332921 94063
Roseville 5388881, California 5332921 95661
Tatiana Vidal
San Francisco 5391959, California 5332921 94115
Rachael Delacruz
Hamden 4835654, Connecticut 4831725 06518
Candace Cotto, RN
Miami 4164138, Florida 4155751 33136
Priscilla De Fatima Madero
Atlanta 4180439, Georgia 4197000 30307
Drew Siskin
Chicago 4887398, Illinois 4896861 60637
Derrick Judkins
Maywood 4901514, Illinois 4896861 60153
Dejan Micic, M.D.
Indianapolis 4259418, Indiana 4921868 46202
Sarah Pardue Brennan, RN CCRP
Kansas City 4273837, Kansas 4273857 66160
Mollie Jackson, M.D.
New Orleans 4335045, Louisiana 4331987 70121
James Gore, M.D.
Boston 4930956, Massachusetts 6254926 02115
Jenna Simes
Boston 4930956, Massachusetts 6254926 02115
Grace Hardwick
Worcester 4956184, Massachusetts 6254926 01604
Anne Foley
Ann Arbor 4984247, Michigan 5001836 48109
Max Macgregor
Detroit 4990729, Michigan 5001836 48202
El-Nachef, MD
Rochester 5043473, Minnesota 5037779 55905
Mary Manyara
Rochester 5043473, Minnesota 5037779 55905
Becky Hofschulte
New Brunswick 5101717, New Jersey 5101760 08901
Susan Cataldo
New York 5128581, New York 5128638 10016
Philip Dulock
New York 5128581, New York 5128638 10021
Dominique Gay
New York 5128581, New York 5128638 10029
Josephine Mitcham
Chapel Hill 4460162, North Carolina 4482348 27599
Rachel Cooke
Portland 5746545, Oregon 5744337 97239
Melissa Hershman, M.D.
Madison 5261457, Wisconsin 5279468 53705
Shelly Zimbric
Milwaukee 5263045, Wisconsin 5279468 53226
Anita Ward
More Details
- NCT ID
- NCT03325855
- Status
- Recruiting
- Sponsor
- American Gastroenterological Association
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.