Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Fecal microbial transplantation is to transplant functional microbiota from the feces of healthy people into the gastrointestinal tract of patients, reconstruct new intestinal microbiota, and realize the treatment of intestinal and extra-intestinal diseases. Compared with ordinary commercial probiotics, FMT is more consistent with the composition of the intestinal microecological structure and can recover intestinal flora to the maximum extent and faster. FMT increases intestinal bacteria production function and helps to restore the systemic immune response so that sepsis pathogens are removed. The aim of this trial was to investigate the clinical effect of FMT in the treatment of patients with severe infections.
详细描述
The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15
- •Aged ≥14 years
- •Patients or their family members agreed to participate in this study
排除标准
- •Advanced tumors or diseases associated with systemic immunosuppression
- •Pregnant women
- •Patients with severe intestinal ulcer or perforation
- •Unable to complete oral administration and no effective artificial feeding pipeline.
研究组 & 干预措施
The experimental group with FMT
The gastrointestinal tube access was established, and the standard preparation of fecal bacteria solution 20ml (frozen at -80 ° C, melted at room temperature before use) was injected through the gastrointestinal tube once a day for 6 consecutive days. The other treatment measures were the same as those of the control group
干预措施: fecal bacteria solution (Drug)
The control group with physiological saline
The gastrointestinal tube access was established, and the standard preparation of physiological saline solution 20ml
干预措施: physiological saline solution (Drug)
结局指标
主要结局
Death
时间窗: up to 28 days in ICU
Clinical outcome
次要结局
- Gut microbiota distribution assessed by 16SrDNA(up to 6 days after fecal microbial transplantation)
研究者
Chen Yuanzhuo
associate chief physician
Shanghai 10th People's Hospital