Real-World Study on Fecal Microbiota Transplantation Long-Term Effectiveness and Safety Statistics

What this Trial Is About

Researchers are conducting a large-scale observational study to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to help restore a balanced gut microbiome. The study includes patients treated for conditions such as recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and some neurological conditions. The study will enroll about 4,000 patients and combines both retrospective and prospective cohorts. It aims to assess remission rates at 3 months, 1 year, and 5 years after FMT, monitor long-term safety and side effects, and explore factors influencing treatment response. Data will be collected from medical records and follow-up visits, with analysis using advanced statistical and machine learning models. Participants will be followed over time to evaluate clinical outcomes, quality of life improvements, and adverse events. Researchers will review symptoms and treatment responses at specific time points, such as 8 weeks and 12 weeks after FMT. The study duration may extend up to five years to capture long-term results. Safety monitoring and data collection will continue throughout the study to support improved clinical use of FMT.

Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics