NCT07261826

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Chen QiYi · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

This is a large-scale observational study aiming 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 restore a balanced gut microbiome. The study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain neurological conditions. The main goals are to: * Assess the disease remission rates at 3 months, 1 year, and 5 years after FMT. * Monitor the long-term safety and any potential side effects. * Identify factors that may influence how well a patient responds to the treatment. This research will use both existing patient data (retrospective cohort) and newly collected data from future patients (prospective cohort). The findings are expected to help improve and standardize FMT treatment for better patient care.

Detailed description

This is a single-center, real-world observational study combining retrospective and prospective cohorts to systematically evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). The study plans to enroll approximately 4,000 patients who have undergone FMT for a range of diseases, including recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal diseases, and certain extra-intestinal disorders. The primary objective is to assess the real-world clinical remission rates at 3 months, 1 year, and 5 years post-FMT. Secondary objectives include evaluating long-term safety and adverse events, measuring improvements in quality of life, and exploring factors (such as delivery route, donor selection, and patient characteristics) that predict treatment success. Data will be collected from medical records and through planned follow-up visits. Advanced statistical and machine learning models will be used to analyze the data and build predictive models. The results of this large-scale study will provide high-quality evidence to support the standardized and precise clinical application of FMT.

Conditions

• Clostridium Difficile Infection Recurrence
• Ulcerative Colitis (UC)
• Crohn Disease (CD)
• Irritable Bowel Syndrome (IBS)
• Chronic Functional Constipation
• Chemotherapy-Induced Colitis
• PD-1 Associated Enteritis
• Autism Spectrum Disorder
• Incomplete Intestinal Obstruction

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: China