Actively Recruiting
Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Led by Chen QiYi · Updated on 2025-12-03
4000
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with one of the target diseases
- Age 3 years or older
- 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 prospective cohort) or consent for clinical data use (for retrospective cohort)
You will not qualify if you...
- Clinical data is severely missing, making efficacy assessment impossible
- Presence of severe complications that may jeopardize safety or confound study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Actively Recruiting
Research Team
C
Chief, Functional Gastrointestinal Surgery
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
9
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