Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Recruiting now
Conditions studied: Clostridium Difficile Infection Recurrence, Ulcerative Colitis (UC), Crohn Disease (CD), Irritable Bowel Syndrome (IBS), Chronic Functional Constipation, Chemotherapy-Induced Colitis, PD-1 Associated Enteritis, Autism Spectrum Disorder, Incomplete Intestinal Obstruction
In brief
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 facts
- Study ID
- NCT07261826
- Run by
- Chen QiYi
- People needed
- 4000
- Starts
- 2025-09-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-12-03
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Clinical data is severely missing, making efficacy assessment impossible.
- Presence of severe complications that may jeopardize safety or confound the study results.
Where it is running
- Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.