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NCT Number: NCT07261826

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

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.

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Key information

Conditions

Clostridium Difficile Infection Recurrence Autism Spectrum Disorder Chemotherapy-Induced Colitis Child Development Disorders, Pervasive Chronic Functional Constipation Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Incomplete Intestinal Obstruction Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Mental Disorders Neurodevelopmental Disorders PD-1 Associated Enteritis Ulcerative Colitis (UC)

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location status: Recruiting

Location contact

Chief, Functional Gastrointestinal Surgery

CONTACT

[email protected]

86+15896453859

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chief, Functional Gastrointestinal Surgery

CONTACT

[email protected]

86+15896453859

Sponsors and collaborators

Lead sponsor

Chen QiYi

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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