The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Number of participants with MRO clearance
研究概览
简要总结
The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).
详细描述
The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: minimum 18 years
- •Positive rectal PCR and/or culture for MRO
- •Ability to speak and understand Danish or English
- •Capable of swallowing the capsules
排除标准
- •Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
- •Severe immune deficiency (defined as current chemo treatment or neurofilocytes < 1000/mm3
- •Pancreatitis, defined by pancreatic amylases above the upper reference limit
- •Planned or recent abdominal surgery (within 14 days)
- •Parenteral nutrition
- •Current antibiotic treatment of the same MRO as intestinal carriage
- •Terminal disease with expected survival under three months
- •Sepsis defined according to Surviving Sepsis Campaign guidelines
- •Pregnant or lactating women
研究组 & 干预措施
FMT (faecal microbiota transplantation)
25-30 capsules of faecal material.
干预措施: Faecal microbiota transplantation (Other)
Placebo
25-30 placebo capsules.
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with MRO clearance
时间窗: 8 weeks
Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative.
次要结局
- Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.(8 weeks and 16 weeks)
- Comparison of the frequency of invasive infections(6 months)
- Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.(6 months)
- Number of participants with MRO clearance(16 weeks)
- Number of participants with adverse events.(8 weeks, 16 weeks and 6 months.)
研究者
Andreas Munk Petersen
Principal Investigator
Hvidovre University Hospital