RecruitingNCT07261826

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


Sponsor

Chen QiYi

Enrollment

4,000 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term data on the effectiveness and safety of fecal microbiota transplantation (FMT) — a treatment where stool from a healthy donor is transferred to a patient to restore healthy gut bacteria — across a variety of diseases. **You may be eligible if...** - You are 3 years or older - You have one of the diseases targeted in this study (such as recurrent C. difficile infection, inflammatory bowel disease, or other eligible conditions) - You have received at least one FMT treatment - You have sufficient medical records available for analysis **You may NOT be eligible if...** - Your medical records are too incomplete to assess outcomes - You had serious complications related to FMT that preclude participation - You do not meet data consent requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

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NCT07261826


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