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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief, Functional Gastrointestinal Surgery | Contact | 86+15896453859 | qiyichen2011@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19528959 | Result | 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. | |
| 27329806 | 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. |
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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 |
| 13592638 | 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. |
| 23160295 | 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. |
| 24798552 | 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. |
| 27383983 | 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. |
| 32433595 | 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. |
| 28393285 | 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. |
| 20203603 | 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. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D043183 | Irritable Bowel Syndrome |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003109 | Colonic Diseases, Functional |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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