Fecal Microbiota Transplant National Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 50
- 主要终点
- Occurrence of treatment related Adverse Events
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
详细描述
This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient Inclusion Criteria
- •Ability to give informed consent
- •Receiving FMT or other gut-related microbiota product within 90 days after providing consent
- •Access to internet and/or telephone
- •Donor Inclusion
- •Ability to give informed consent
- •Providing stool sample for FMT
排除标准
- •Incarceration
结局指标
主要结局
Occurrence of treatment related Adverse Events
时间窗: over 10 Years
Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
Disease Re-occurrence Following FMT
时间窗: over 10 Years
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
次要结局
未报告次要终点