National Registry Study for Patients Receiving Fecal Microbiota Transplant or Gut Microbiome Treatments

What this Trial Is About

Researchers are studying patients who receive fecal microbiota transplantation FMT or other gut-related microbiota products to understand the short-term and long-term safety and effectiveness of these treatments. This national data registry aims to collect detailed information on how FMT is performed, why it is done, and the baseline health of patients receiving it. The study is observational and will enroll around 4,000 patients at 75 sites across North America. Participants will undergo FMT or receive related microbiota products, and information about the donor and recipient screening, preparation, and delivery methods will be collected from each site. The registry will track patients for up to 10 years after their treatment, with follow-up data gathered from healthcare providers at 1 month, 6 months, 1 year, and 2 years post-FMT, as well as annual communication with patients for the full duration. During the study, researchers will collect data on any treatment-related side effects and whether the original disease returns after FMT. Follow-up will include regular assessments to monitor safety and effectiveness over time. Participants will be asked to provide information through healthcare provider reports and direct contact, with the total participation lasting up to 10 years to ensure long-term monitoring.

Fecal Microbiota Transplant National Registry