NCT05526807终止不适用
Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To assess tolerability to oral ursodeoxycholic acid
研究概览
简要总结
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days
排除标准
- •• Pregnant or Breast-feeding
- •Gall bladder inflammation
- •Frequent episodes of biliary colic
- •Occlusion of the common bile duct or cystic duct
- •Active small intestinal inflammation
- •Previous resection of distal small intestine
- •Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
- •Diarrhoea (from any cause) at study initiation
- •hypersensitivity to bile acids or any excipient of the formulation
- •Life expectancy less than 6 months
研究组 & 干预措施
Ursodeoxycholic acid
Experimental
Only one arm - subjects receiving ursodeoxycholic acid
干预措施: Ursodeoxycholic acid (Drug)
结局指标
主要结局
To assess tolerability to oral ursodeoxycholic acid
时间窗: 6 weeks
Assess for side effects
次要结局
- To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid(12 weeks)
研究者
研究点 (1)
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