Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.
研究概览
简要总结
This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.
详细描述
This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Care Provider)
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
- •Age >18;
- •Vancomycin Resistant Enterococcus intestinal carriage
排除标准
- •Neutropenia <1000 /mm3,
- •Immunosuppressive drugs,
- •Inhalation
结局指标
主要结局
Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.
次要结局
未报告次要终点