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临床试验/NCT04181112
NCT04181112Unknown不适用

Fecal Microbiota Transplantation (FMT) for Intestinal Decolonization of Multidrug-resistant Opportunistic Pathogens

University of British Columbia2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.

研究概览

简要总结

This is a trial designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT using enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.

详细描述

Contact the study principal investigator for the study protocol.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.

时间窗: 3 years

次要结局

  • Compare proportions, type and timing of adverse events post-FMT(3 years)
  • Proportions of recolonization over 180 days(3 years)
  • Timing of recolonization over 180 days(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amee Manges

Associate Professor

University of British Columbia

研究点 (2)

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