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

November 22, 2025 updated by: Chen QiYi

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chief, Functional Gastrointestinal Surgery
  • Phone Number: 86+15896453859
  • Email: qiyichen2011@163.com

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
          • Chief, Functional Gastrointestinal Surgery
          • Phone Number: 86+15896453859
          • Email: qiyichen2011@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Autism Spectrum Disorder
Clostridium Difficile Infection Recurrence
Ulcerative Colitis (UC)
Crohn Disease (CD)
Irritable Bowel Syndrome (IBS)
chronic functional constipation
Chemotherapy-Induced Colitis
PD-1 associated enteritis
incomplete intestinal obstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
8-Week Clinical Cure of Recurrent CDI
Time Frame: 8 weeks after the final FMT treatment
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.
8 weeks after the final FMT treatment
Treatment Response in Chronic Constipation at 8 Weeks
Time Frame: 8 weeks after the final FMT treatment
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.
8 weeks after the final FMT treatment
Corticosteroid-Free Clinical Remission in IBD at 8 Weeks
Time Frame: 8 weeks after the final FMT treatment
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.
8 weeks after the final FMT treatment
Symptom Relief in IBS at 3 Months
Time Frame: 3 months after the final FMT treatment
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.
3 months after the final FMT treatment
Treatment Response in Autism at 12 Weeks
Time Frame: 12 weeks after the final FMT treatment
Percentage of participants meeting the response criteria at Week 12, defined as an Autism Behavior Checklist (ABC) score <31 AND a score of 1 (very much improved) on the Clinical Global Impression-Improvement (CGI-I) scale.
12 weeks after the final FMT treatment
Symptom Improvement in Incomplete Bowel Obstruction
Time Frame: 8 weeks after the final FMT treatment
Percentage of participants achieving a reduction of >50% in abdominal distension and/or pain, AND weaning off parenteral nutrition.
8 weeks after the final FMT treatment
Symptom Resolution in Drug-Induced Enteritis
Time Frame: 8 weeks after the final FMT treatment
Percentage of participants achieving symptom resolution, defined as a reduction to CTCAE grade ≤1 (stool frequency increase <4 times per day from baseline, without abdominal pain, hematochezia, or mucus), AND requiring corticosteroids <10 mg prednisone equivalent per day.
8 weeks after the final FMT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen QiYi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

November 22, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSY-IEC-6.0/25K221/P01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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