临床试验/NCT02326636

NCT02326636已完成不适用

Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

University of California, Irvine1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2014年4月最近更新: 2023年8月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of California, Irvine
入组人数: 37
试验地点: 1
主要终点: The recurrence rate of Clostridium difficile 4 weeks after FMT.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.

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 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

The recurrence rate of Clostridium difficile 4 weeks after FMT.

时间窗: Four weeks

次要结局

Satisfaction with the FMT procedure. ( satisfaction questionnaire )(Up to 24 weeks)
Quality of life before and 4 weeks after FMT.(Four weeks)
The rate of adverse events that may be related to FMT.(Up to 24 weeks)
Alternate treatments needed for Clostridium difficile before and after FMT.(Up to 24 weeks)
Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.(Four weeks)

研究者

发起方

University of California, Irvine

申办方类型

Other

责任方

Principal Investigator

主要研究者

Nimisha Parekh

Associate Clinical Professor

University of California, Irvine

研究点 (1)

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