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
Conditions
Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome
Recruitment Status
Recruiting
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.
Eligibility 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
Intervention
Intervention Type
Intervention Name
Other
None - Observational
Gender
All
Min Age
N/A
Max Age
N/A
Download Date
January 31, 2024
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: