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 Genders
- 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
Kansas City, Kansas 66160
Mollie Jackson, M.D.
More Details
- 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.