The Effect of a Lactobacillus Probiotic Strain on Eradication of Vancomycin Resistant Enterococcus Faecium (VRE) in Non-symptomatic VRE-carriers - a Multicenter, Randomized, Placebo-controlled, Parallel-group Study With 4 Weeks Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Number of subjects with cleared VRE colonization at week 4
研究概览
简要总结
This study will evaluate the efficacy of a probiotic lactobacillus strain in eradicating VRE in non-symptomatic carriers after 4 weeks of treatment. It will also evaluate the long-term efficacy after 8,16 and 24 weeks.
详细描述
With the increased number of Vancomycin-Resistant Enterococcus faecium (VRE) infected/colonized people it is evident that new treatment options are needed to reduce the number of VRE cases. One such option could be to use probiotics. We hypothesize that treatment with a probiotic lactobacillus strain can reduce the number of VRE carriers significantly. The aim is to investigate if this strain can eradicate VRE in non-symptomatic VRE-carriers measured as the number of subjects without VRE colonization at week 4.
This is a multi-center, randomized, double-blind, placebo-controlled parallel-group trial in non-symptomatic VRE-carriers.
The Trial consists of a 4 weeks intervention period followed by a 20-week follow-up period.
After patients have been confirmed as carriers of VRE, the subjects are randomized to 4 weeks' treatment with a lactobacillus probiotic strain (60 billion CFU per day) or to placebo. Subjects' VRE carrier-state is assessed at weeks 4, 8, 16 and 24, by an in-house PCR analysis. Stool samples are collected before intervention (baseline) and at week 4, 8, 16 and week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with VRE colonization (positive faecal swab)
- •Subjects over 18 years of age
- •Provided voluntary written informed consent
排除标准
- •Symptomatic VRE infection
- •Serious immunodeficiency
- •Pancreatitis
- •Planned or recent intraabdominal operation within a time window of14 days)
- •Parenteral nutrition
- •Antibiotic treatment for VRE one month prior to inclusion
- •Terminal disease with expected survival time < 3 month
- •Probiotic consumption within two weeks prior enrollment
结局指标
主要结局
Number of subjects with cleared VRE colonization at week 4
时间窗: 4 weeks
Fecal sample diagnosed by pcr and detection of the vanA gene
次要结局
- Clearance of VRE colonization at week 8, 16 and 24 respectively(8, 16 and 24 weeks)
- Changes in fecal microbiota composition(24 weeks)
- Number of VRE infections (isolation from non-intestinal foci)(24 weeks)
- Colonization with probiotic lactobacillus strain(24 weeks)
研究者
Andreas Munk Petersen
Md, Phd, Consultant
Hvidovre University Hospital