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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorChen QiYi

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Clinical data is severely missing, making efficacy assessment impossible.

Presence of severe complications that may jeopardize safety or confound the study results.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

4,000 Participants
are grouped into 9 trial groups

9

Trial groups

See each trial group below.

Sponsors and collaborators

Chen QiYi

Lead sponsor

Shanghai 10th People's Hospital

Sponsor institution