Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Resolution of Clostridium difficile-Associated disease (CDAD)
研究概览
简要总结
Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).
详细描述
Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.
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
- •age 18 or higher
- •documented recurrence of Clostridium difficile
排除标准
- 未提供
结局指标
主要结局
Resolution of Clostridium difficile-Associated disease (CDAD)
时间窗: 8 weeks
Number of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8
次要结局
- Negative CD test week 8(8 weeks)
- Clinical effect week 8(8 weeks)
研究者
Christian Hvas
Associate professor, MD PhD
University of Aarhus