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

NCT07261826 | Recruiting DMC

• 1 other identifier: SHSY-IEC-6.0/25K221/P01
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• 8-Week Clinical Cure of Recurrent CDI

  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

  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

  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

  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

  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

  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

  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

Study Arms (9)

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

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Chen QiYi: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (9)

• Rupnik M, Wilcox MH, Gerding DN. Clostridium difficile infection: new developments in epidemiology and pathogenesis. Nat Rev Microbiol. 2009 Jul;7(7):526-36. doi: 10.1038/nrmicro2164.

  PMID: 19528959 RESULT

• Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.

  PMID: 27329806 RESULT

• EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.

  PMID: 13592638 RESULT

• Zhang F, Luo W, Shi Y, Fan Z, Ji G. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol. 2012 Nov;107(11):1755; author reply p.1755-6. doi: 10.1038/ajg.2012.251. No abstract available.

  PMID: 23160295 RESULT

• Petersen C, Round JL. Defining dysbiosis and its influence on host immunity and disease. Cell Microbiol. 2014 Jul;16(7):1024-33. doi: 10.1111/cmi.12308. Epub 2014 Jun 2.

  PMID: 24798552 RESULT

• Baumler AJ, Sperandio V. Interactions between the microbiota and pathogenic bacteria in the gut. Nature. 2016 Jul 7;535(7610):85-93. doi: 10.1038/nature18849.

  PMID: 27383983 RESULT

• Zheng D, Liwinski T, Elinav E. Interaction between microbiota and immunity in health and disease. Cell Res. 2020 Jun;30(6):492-506. doi: 10.1038/s41422-020-0332-7. Epub 2020 May 20.

  PMID: 32433595 RESULT

• Rowland I, Gibson G, Heinken A, Scott K, Swann J, Thiele I, Tuohy K. Gut microbiota functions: metabolism of nutrients and other food components. Eur J Nutr. 2018 Feb;57(1):1-24. doi: 10.1007/s00394-017-1445-8. Epub 2017 Apr 9.

  PMID: 28393285 RESULT

• Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

  PMID: 20203603 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Irritable Bowel Syndrome; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colonic Diseases, Functional; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Chief, Functional Gastrointestinal Surgery

CONTACT

86+15896453859; qiyichen2011@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Functional Gastrointestinal Surgery

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CN (1)