Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Resolution of CD-associated diarrhea (CDAD) week 8
研究概览
简要总结
Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.
In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.
详细描述
This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
- •Age 18 years or higher.
排除标准
- •Pregnancy
- •Does not speak or understand the Danish language
- •Current antibiotic treatment other than vancomycin
- •Current treatment with potential interations with vancomycin
- •Allergy to vancomycin
- •Previous anaphylactic reactions due to food allergies
- •Continuous need for proton pump inhibitor
- •Documented gastroparesis
- •Fulminant CDI
结局指标
主要结局
Resolution of CD-associated diarrhea (CDAD) week 8
时间窗: 8 weeks following treatment
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Mortality week 8
时间窗: 8 weeks following treatment
In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.
次要结局
- Negative CD toxin-test week 1(1 week following treatment)
- Resolution of CD-associated diarrhea (CDAD) week 1(1 week following treatment)
- Mortality week 8(8 weeks)
- Colectomy rate week 8(8 weeks)
- Health-related quality of life(8 weeks)
- Negative CD toxin-test week 8(8 weeks following treatment)
研究者
Christian Hvas
MD PhD Consultant
Aarhus University Hospital