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RECRUITING
NCT07261826

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

Sponsor: Chen QiYi

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2025-09-01

Completion Date

2028-06-30

Last Updated

2025-12-03

Healthy Volunteers

No

Locations (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China