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.
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.
Clinical data is severely missing, making efficacy assessment impossible.
Presence of severe complications that may jeopardize safety or confound the study results.
The study population consists of approximately 4,000 patients who have undergone Fecal Microbiota Transplantation (FMT) at our center. This includes a retrospective cohort of about 3,000 patients treated between January 2017 and August 2025, whose data will be collected from medical records, and a prospective cohort of about 1,000 new patients to be enrolled from September 2025 to June 2028. Participants must be ≥3 years of age and diagnosed with one of the target diseases, including but not limited to recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain extra-intestinal diseases. All participants must have received at least one FMT treatment and have available baseline data. This real-world study aims to include a broad patient population reflective of routine clinical practice.
Cohort
Other
Not listed
9
Trial groupsSee each trial group below.
8-Week Clinical Cure of Recurrent CDI
Percentage of participants with sustained clinical cure at 8 weeks post-treatment, defined as persistent resolution of diarrhea (formed stools \<3 times per day) AND a negative test for C. difficile toxin.
Treatment Response in Chronic Constipation at 8 Weeks
Percentage of participants meeting all of the following criteria at 8 weeks: \>3 complete spontaneous bowel movements per week, Bristol Stool Form Scale (BSFS) type 3-5, and a reduction of \>30% in the Patient Assessment of Constipation Symptoms (PAC-SYM) score.
Corticosteroid-Free Clinical Remission in IBD at 8 Weeks
Percentage of participants achieving corticosteroid-free clinical remission. For Ulcerative Colitis (UC), defined as a Mayo score ≤2 with no subscore \>1. For Crohn's Disease (CD), defined as a Crohn's Disease Activity Index (CDAI) score \<150.
Symptom Relief in IBS at 3 Months
Percentage of participants experiencing relief of abdominal pain or discomfort related to defecation for 3 consecutive months, with stool consistency rated as Bristol Stool Form Scale (BSFS) type 3-5.
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Chen QiYi
Lead sponsor
Shanghai 10th People's Hospital
Sponsor institution
