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Fecal Microbiome Transplant National Registry

粪便微生物组移植国家登记处

基本信息

批准号：
9326131
负责人：
Colleen Renee Kelly
金额：
$ 61.47万
依托单位：
AMERICAN GASTROENTEROLOGICAL ASSN/INST
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-04 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9326131
关键词：
Adoption Adverse event American Animal Model Archives Biometry Bypass Centers for Disease Control and Prevention (U.S.)Characteristics Chronic Disease Clinical Clinical Data Clinical effectiveness Clostridium difficile Collection Communities Conflict of Interest Consensus Data Data Element Development Disease Education Educational workshop Effectiveness Effectiveness of Interventions Electronic Mail Elements Enrollment Ethics Feces Foundations Generations Goals Health Human Human Microbiome Incidence Infection Information Distribution Institutional Review Boards Intervention Investigation Knowledge Laboratories Leadership Link Metadata Methodology Modality Monitor Observational Study Outcome Participant Pathogenesis Pathway interactions Patient Education Patients Physicians Prospective cohort Randomized Controlled Trials Recurrence Registries Reporting Research Research Infrastructure Resources Risk Role Safety Sampling Scientific Advances and Accomplishments Signal Detection Analysis Site Source Standardization Statistical Data Interpretation Techniques Therapeutic Therapeutic Intervention United States United States National Institutes of Health Work adverse outcome base biobank clinical application clinical practice comparative effectiveness data registry data sharing discrete data effective therapy experience fecal transplantation follow-up gut microbiome gut microbiota interest microbiota transplantation novel strategies outreach program prospective screening tool

项目摘要

Project Summary Rapidly accumulating evidence suggests that modifying gut microbiota may promote health or treat disease, with fecal microbiota transplantation (FMT) for C. difficile infection (CDI) being the first successful clinical application of this concept. Given the rising incidence of CDI and the lack of effective therapies for recurrent CDI, the use of FMT is growing rapidly, despite a paucity of clinical data and despite the theoretical risk that transfer of gut microbiota may induce chronic diseases. The early adoption and expansion of FMT in clinical practice has bypassed the standard investigatory pathway and preceded large randomized controlled trials that typically evaluate efficacy and contribute important short- and long-term safety data. In order to overcome this deficit in knowledge and experience, we propose to develop a national FMT registry. The goal of this proposal is to collect clinical data from both FMT donors and recipients for the following purposes: 1) To assess short- and long-term safety; 2) to gather information on practice in the U.S. and assess effectiveness of the intervention; 3) to promote scientific investigation; and 4) to aid practitioners and trial sponsors in satisfying regulatory requirements. This registry will prospectively enroll patients who undergo FMT at sites throughout the U.S. Information on FMT methodology, FMT indication, as well as baseline data on donors and recipients will be collected from each site. Patients will be followed at regular intervals for up to 10 years after FMT for pre-defined and spontaneously reported adverse events and for pre-defined outcomes of effectiveness. The registry will facilitate statistical analyses for signal detection, generation of descriptive data, and the conduct of comparative effectiveness studies. A prospective cohort of 4,000 FMT patients will provide precise estimates of the incidence of safety and effectiveness endpoints in real-world practice and rule out uncommon adverse events with high confidence. This registry will link to an independent biobank that will collect, archive, and analyze approximately 3,000 fecal samples from the donors as well as recipients, providing a rich source for studying manipulation of the gut microbiota in humans. The leadership of the American Gastroenterological Association (AGA) and its partner organizations have worked together to develop the plans for this registry, which will be an extremely important tool to assess short-term safety, identify potential long-term consequences, determine effectiveness in real-world practice, help standardize best FMT practice, and gauge the potential consequences of manipulating the gut microbiome in human health and disease.

项目总结