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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 8-Week Clinical Cure of Recurrent CDI [Срок оценки: 8 weeks after the final FMT treatment]
• Treatment Response in Chronic Constipation at 8 Weeks [Срок оценки: 8 weeks after the final FMT treatment]
• Corticosteroid-Free Clinical Remission in IBD at 8 Weeks [Срок оценки: 8 weeks after the final FMT treatment]
• Symptom Relief in IBS at 3 Months [Срок оценки: 3 months after the final FMT treatment]
• Treatment Response in Autism at 12 Weeks [Срок оценки: 12 weeks after the final FMT treatment]
• Symptom Improvement in Incomplete Bowel Obstruction [Срок оценки: 8 weeks after the final FMT treatment]
• Symptom Resolution in Drug-Induced Enteritis [Срок оценки: 8 weeks after the final FMT treatment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai Tenth People's Hospital — Шанхай

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07261826 · SHSY-IEC-6.0/25K221/P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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