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

Inclusion Criteria5

  • Diagnosed with one of the target diseases.
  • Age ≥ 3 years.
  • Have received at least one Fecal Microbiota Transplantation (FMT) treatment.
  • Availability of complete baseline and follow-up data for analysis.
  • Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort).

Exclusion Criteria2

  • Clinical data is severely missing, making efficacy assessment impossible.
  • Presence of severe complications that may jeopardize safety or confound the study results.

Locations(1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07261826


Related Trials