Long-term effectiveness and safety of fecal microbiota transplantation

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

This project will follow about 4,000 people who have had fecal microbiota transplantation to see if it helps keep them in remission and is safe over 3 months, 1 year, and 5 years for conditions like recurrent C. difficile, IBD, IBS, and chronic constipation.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: Shanghai 10th People's Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07261826 on ClinicalTrials.gov

What this trial studies

This single-center, real-world observational project combines retrospective and prospective cohorts to collect clinical records and scheduled follow-up from roughly 4,000 patients who received FMT for recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and related conditions. Primary outcomes are clinical remission rates at 3 months, 1 year, and 5 years post-FMT, with secondary outcomes including long-term safety, adverse events, and quality-of-life changes. The study will examine how delivery route, donor selection, and patient characteristics influence results using conventional statistics and machine learning models. Findings are intended to provide large-scale evidence to help standardize and improve clinical use of FMT.

Who should consider this trial

Good fit: Ideal candidates are people aged 3 years and older who have received at least one FMT for recurrent C. difficile, inflammatory or functional bowel disorders, or related conditions and have available baseline and follow-up data.

Not a fit: Patients with severely incomplete clinical records, those with serious complications that would confound outcome measurement, or those unable to complete follow-up are unlikely to benefit from this research.

Why it matters

Potential benefit: If successful, the findings could help clinicians personalize FMT, improve long-term remission rates, and identify and reduce safety risks for patients.

How similar studies have performed: Randomized trials have shown strong success of FMT for recurrent C. difficile, while results for IBD and functional bowel disorders are mixed and long-term, large-scale real-world data across multiple conditions remain limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Chief, Functional Gastrointestinal Surgery

Conditions: Clostridium Difficile Infection Recurrence, Ulcerative Colitis, Crohn Disease, Irritable Bowel Syndrome, Chronic Functional Constipation, Chemotherapy-Induced Colitis, PD-1 Associated Enteritis, Autism Spectrum Disorder