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

Chen QiYi

Status

Enrolling

Conditions

Chemotherapy-Induced Colitis

Autism Spectrum Disorder

Clostridium Difficile Infection Recurrence

Incomplete Intestinal Obstruction

Chronic Functional Constipation

Ulcerative Colitis (UC)

Irritable Bowel Syndrome (IBS)

Crohn Disease (CD)

PD-1 Associated Enteritis

Study type

Observational

Funder types

Other

Identifiers

NCT07261826

SHSY-IEC-6.0/25K221/P01

Details and patient eligibility

About

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.

Full description

This is a single-center, real-world observational study combining retrospective and prospective cohorts to systematically evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT).

The study plans to enroll approximately 4,000 patients who have undergone FMT for a range of diseases, including recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal diseases, and certain extra-intestinal disorders.

The primary objective is to assess the real-world clinical remission rates at 3 months, 1 year, and 5 years post-FMT. Secondary objectives include evaluating long-term safety and adverse events, measuring improvements in quality of life, and exploring factors (such as delivery route, donor selection, and patient characteristics) that predict treatment success. Data will be collected from medical records and through planned follow-up visits. Advanced statistical and machine learning models will be used to analyze the data and build predictive models.

The results of this large-scale study will provide high-quality evidence to support the standardized and precise clinical application of FMT.

Enrollment

4,000 estimated patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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.