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

NCT07261826 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

  • 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 & Collaborators

  • Chen QiYi

    lead OTHER

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261826 on ClinicalTrials.gov