跳至主要内容
临床试验/NCT05990972
NCT05990972已完成不适用

To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Changes in defecation frequency after FMT.

研究概览

简要总结

Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.

排除标准

  • non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.

结局指标

主要结局

Changes in defecation frequency after FMT.

时间窗: Baseline and three months after treatment

Changes in gut microbiota after FMT.

时间窗: Baseline and three months after treatment.

次要结局

未报告次要终点

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huanlong Qin

Clinical Professor

Shanghai 10th People's Hospital

研究点 (1)

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