Fact CheckerSign in

NCT07261826Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
4000 (estimated)
First submitted
22 Nov 2025
Start date
1 Sept 2025
Primary completion date
30 Jun 2028
Lead sponsor
Chen QiYi
NCT number
NCT07261826

What you commit to

  • Study type: Observational
  • Planned participants: 4000
  • From 1 Sept 2025 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Clinical data is severely missing, making efficacy assessment impossible.
  • Presence of severe complications that may jeopardize safety or confound the study results.

Who the study is looking for

  • 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).

Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Tenth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.