Long-term effectiveness and safety of fecal microbiota transplantation
Official title: Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Run by Shanghai 10th People's Hospital · NCT07261826 · Data updated 2026-11-12
This project will follow about 4,000 people who have had fecal microbiota transplantation to see if it helps keep them in remission and is safe over 3 months, 1 year, and 5 years for conditions like recurrent C. difficile, IBD, IBS, and chronic constipation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years and up |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT07261826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 3 years and older who have received at least one FMT for recurrent C. difficile, inflammatory or functional bowel disorders, or related conditions and have available baseline and follow-up data.
✕Probably not a fit
Patients with severely incomplete clinical records, those with serious complications that would confound outcome measurement, or those unable to complete follow-up are unlikely to benefit from this research.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, real-world observational project combines retrospective and prospective cohorts to collect clinical records and scheduled follow-up from roughly 4,000 patients who received FMT for recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and related conditions. Primary outcomes are clinical remission rates at 3 months, 1 year, and 5 years post-FMT, with secondary outcomes including long-term safety, adverse events, and quality-of-life changes. The study will examine how delivery route, donor selection, and patient characteristics influence results using conventional statistics and machine learning models. Findings are intended to provide large-scale evidence to help standardize and improve clinical use of FMT.
Why it matters
Potential benefit: If successful, the findings could help clinicians personalize FMT, improve long-term remission rates, and identify and reduce safety risks for patients.
How similar studies have gone: Randomized trials have shown strong success of FMT for recurrent C. difficile, while results for IBD and functional bowel disorders are mixed and long-term, large-scale real-world data across multiple conditions remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Clinical data is severely missing, making efficacy assessment impossible. * Presence of severe complications that may jeopardize safety or confound the study results.
Where it's running
-
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Chief, Functional Gastrointestinal Surgery
- Email: qiyichen2011@163.com
- Phone: 86+15896453859
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Familial IBD Early Risk
This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.
-
Biomarker Discovery and Validation Platform for Inflammatory Bowel Disease
Researchers are testing biomarker models to see if they can measure and predict inflammation and treatment response in people with Crohn's disease, ulcerative colitis, or related IBD.
-
Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease
This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.
-
Individualizing Anti-TNF Therapy in IBD
This study tests whether genetic markers can predict which anti-TNF–naïve IBD patients will respond to their first anti-TNF treatment.
-
LRG levels and IBD activity in European patients
This study will test whether Leucine-rich α2-glycoprotein (LRG) levels reflect disease activity in adults with Crohn’s or ulcerative colitis who are undergoing routine endoscopy in Europe.
-
CEDUR — German inflammatory bowel disease registry
This registry collects real-world health and treatment information from adults with Crohn's disease, ulcerative colitis, or indeterminate colitis in Germany to see how care, effectiveness, safety, and costs play out in routine practice.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.