Long-term results and safety of fecal microbiota transplantation for gut conditions
Follows people who receive stool transplants for bowel and gut conditions.
Plain-language title generated from the registry record
Registry title: Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Tenth People's HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chen QiYi
- Trial code
- NCT07261826
- Record updated
- 3 December 2025
- Original description
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.Read full original descriptionShow less
Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
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.
Inclusion: 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: Clinical data is severely missing, making efficacy assessment impossible; Presence of severe complications that may jeopardize safety or confound the study results.