Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT.
研究概览
简要总结
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
详细描述
The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides 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
- Double (Participant, Investigator)
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
- •At least twice recurrent CDI*
- •Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)
- •Other causes of diarrhea have been excluded based on clinical data
- •Age over 18 years
- •Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin)
- •No other antibiotic courses
- •Able to sign the consent form or accept it electronically via Suomi.fi identification
- •definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection
排除标准
- •Pregnancy
- •Continuous need for antibiotic treatment
- •Previous anaphylactic reactions to any food
- •Gastroparesis
- •Life-threatening fulminant CDI
- •Life expectancy less than 1 year
- •Inability to sign a consent form for the study
研究组 & 干预措施
Patients receiving active treatment
CDI patients receiving healthy donor stool by capsules
干预措施: Healthy donor stool (Biological)
Placebo arm
Placebo FMT capsules
干预措施: placebo capsule (Biological)
结局指标
主要结局
Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT.
时间窗: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).
The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.
次要结局
- Number of patients with side effects after FMT capsules.(One, four and twelve weeks after FMT (placebo or active FMT).)
研究者
Perttu Arkkila
Professor
Helsinki University Central Hospital