NCT03732131招募中不适用
Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
Joint Authority for Päijät-Häme Social and Health Care1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The long term effects of FMT -questionnaire
研究概览
简要总结
The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years age
- •receiving FMT for rCDI or any other madical condition
- •written consent
- •Not included in other FMT trials
排除标准
- •Unable to provide written consent
- •< 18 years age
- •Included in other FMT-trial
结局指标
主要结局
The long term effects of FMT -questionnaire
时间窗: 10 years
The questionnaire has 52 questions. Weight and height are asked and appearance of certain symptoms. The answers are mostly yes or no. The questionnaire is not validated and it is descriptive and the answers are not scored.
次要结局
未报告次要终点
研究者
研究点 (1)
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