A Prospective, Case-series Study of Fecal Microbiota Transplantation for the Selective Intestinal Decolonization of Multidrug-resistant, Pathogenic Enterobacteriaceae
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits.
研究概览
简要总结
This is a proof-of-principle research study 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 by 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 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 primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits.
时间窗: 6 months
次要结局
- Estimate the proportion of patients who become re-colonized following FMT.(6 months)
- Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)).(6 months)
研究者
Amee Manges
Associate Professor
University of British Columbia