FMTFMT Methodology and Patient Registry for Long-Term Safety and Effectiveness

This study is about the Fecal Microbiota Transplant (FMT), a procedure that involves transplanting healthy bacteria from a donor into a patient's gut. The study aims to enroll 4,000 patients across 75 sites in North America who are undergoing FMT. The importance of this study lies in understanding the effectiveness and safety of FMT, as it could potentially offer a new treatment approach for various gut-related conditions. The study will collect information on the FMT methodology used, the reasons for FMT, and the patients' health status before the procedure. After the FMT, patients will be regularly monitored for up to 10 years. This includes follow-ups with the healthcare provider at 1 month, 6 months, 1 year, and 2 years post-FMT, and direct communication with patients annually until the 10th year. The study will assess the short-term and long-term safety and effectiveness of FMT. The effectiveness will be measured by monitoring disease re-occurrence after treatment. Safety will be evaluated by tracking any treatment-related adverse events, such as surgeries, infections, hospitalizations, life-threatening events, death, and newly diagnosed diseases.