The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.
研究概览
简要总结
The exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.Simultaneously optimizing the conditions during the FMT process, identifying the most effective treatment methods to enhance the therapeutic outcomes of FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being able to tolerate a nasoenteric tube or swallow a capsule.
排除标准
- •Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.
结局指标
主要结局
Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.
时间窗: 0day, 7days, 30days, 3 months, 6months,12 months
Performing 16S rRNA sequencing, metagenomic sequencing, and metabolite analysis on the samples.
Comparing the therapeutic efficacy of patients after FMT.
时间窗: 0day, 7days, 30days, 3 months, 6months,12 months
Through conducting relevant questionnaire surveys with patients, we can gain insights into the therapeutic efficacy of patients after undergoing FMT.
次要结局
未报告次要终点
研究者
Huanlong Qin
Dean of the hospital
Shanghai 10th People's Hospital