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, California 94063
Roseville, California 95661
Tatiana Vidal
San Francisco, California 94115
Rachael Delacruz
Hamden, Connecticut 06518
Candace Cotto, RN
Miami, Florida 33136
Priscilla De Fatima Madero
Atlanta, Georgia 30307
Drew Siskin
Chicago, Illinois 60637
Derrick Judkins
Maywood, Illinois 60153
Dejan Micic, M.D.
Indianapolis, Indiana 46202
Sarah Pardue Brennan, RN CCRP
Kansas City, Kansas 66160
Mollie Jackson, M.D.
New Orleans, Louisiana 70121
James Gore, M.D.
Boston, Massachusetts 02115
Jenna Simes
Boston, Massachusetts 02115
Grace Hardwick
Worcester, Massachusetts 01604
Anne Foley
Ann Arbor, Michigan 48109
Max Macgregor
Detroit, Michigan 48202
El-Nachef, MD
Rochester, Minnesota 55905
Mary Manyara
Rochester, Minnesota 55905
Becky Hofschulte
New Brunswick, New Jersey 08901
Susan Cataldo
New York, New York 10016
Philip Dulock
New York, New York 10021
Dominique Gay
New York, New York 10029
Josephine Mitcham
Chapel Hill, North Carolina 27599
Rachel Cooke
Portland, Oregon 97239
Melissa Hershman, M.D.
Madison, Wisconsin 53705
Shelly Zimbric
Milwaukee, Wisconsin 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.