Fecal Microbiota Transplant National Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess short-term and long-term safety of FMT and other gut-related-microbiota products
研究概览
简要总结
A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Providing stool sample for FMT
排除标准
- •Incarceration
结局指标
主要结局
To assess short-term and long-term safety of FMT and other gut-related-microbiota products
时间窗: 10 years
The safety of FMT is currently the greatest concern related to its use, and characterizing the safety of FMT and subsequent gut-related-microbiota products is the primary goal of the Registry. Short-term adverse events relate primarily to the method of delivery (e.g. colonoscopy) and to acute infections or other AEs from the donor fecal material and should be readily definable and quantifiable.The human-to-human transfer of feces may be associated with long-term health risks to the recipient because the gut microbiota is composed of many components that have not been characterized and can change over time in ways that cannot be currently predicted. It is imperative to determine if FMT leads to unintended development of serious conditions due to the transfer of gut microbiota. In addition to infections, the possibility that gut microbiota associated with a disease phenotype will be transplanted and result in chronic disease in recipients must be assessed.
次要结局
- To gather information on FMT practice in North America(10 years)
- To characterize effectiveness of FMT and other gut-related-microbiota products.(10 years)
- To promote scientific investigation.(10 years)
- To aid practitioners and sponsors in satisfying regulatory requirements(10 years)