Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
研究概览
简要总结
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin
排除标准
- •Pregnancy or breastfeeding
- •Does not speak or understand the Danish language
- •Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
- •fulminant colitis which contraindicates medical treatment
- •physician's evaluation that the patient cannot tolerate project inclusion
研究组 & 干预措施
FMT
Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor
干预措施: Fecal microbiota transplantation (Other)
Fidaxomicin
10 days fidaxomicin 200 mg x 2 daily
干预措施: Fidaxomicin (Drug)
Vancomycin
10 days vancomycin 125 x 4 daily
干预措施: Vancomycin (Drug)
结局指标
主要结局
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
时间窗: 8 weeks
Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment
次要结局
- Number of patients with clinical resolution 1 week after primary treatment(1 week)
- Number of patients with clinical resolution 8 weeks after primary treatment(8 weeks)
- Number of patients with clinical resolution 26 weeks after primary treatment(26 weeks)
- Number of patients with microbiological resolution week 1(1 week)
- Number of patients with microbiological resolution week 8(8 weeks)
- Number of patients with microbiological resolution week 26(26 weeks)
- Number of patients with global resolution (Clinical and microbiological resolution) week 1(1 week)
- Number of patients with global resolution (Clinical and microbiological resolution) week 26(26 weeks)
- Numerical change in quality of life (EQ5D-3L) week 8 and 26(8 and 26 weeks)
- Microbiota pattern changes 1, 8 and 26 weeks(1, 8 and 26 weeks)