The Use of the Probiotic, Lactobacillus Rhamnosus GG to Evaluate Colonization With Antimicrobial Resistant Bacteria in High Risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on a ventilator.
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
- None
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
- •Adults ≥ 18 years old
- •Admission to the Medical ICU
- •Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours
排除标准
- •Pregnancy
- •Immunosuppression
- •Prosthetic valve or vascular graft
- •Cardiac trauma
- •Pancreatitis
- •History of rheumatic fever
- •Endocarditis or congenital cardiac abnormality
- •Gastroesophageal or intestinal injury or foregut surgery during the current admission
- •Oropharyngeal mucosal injury
- •Placement of a tracheostomy
研究组 & 干预措施
Standard of Care
Patients in the control arm will receive standard care
Probiotic
Patients randomized to probiotic therapy will receive 1 capsule containing 1010 cells of Lactobacillus rhamnosus GG on a twice-daily basis
干预措施: Lactobacillus rhamnosus GG (Dietary Supplement)
结局指标
主要结局
Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE
时间窗: Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)
Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.
次要结局
未报告次要终点