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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Chief, Functional Gastrointestinal Surgery
qiyichen2011@163.com
86+15896453859
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 4000
Treatments
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
Sponsors
Leads: Chen QiYi

This content was sourced from clinicaltrials.gov

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