Randomized Controlled Trial of Lactobacillus Rhamnosus GG to Promote Intestinal Health
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Number of Participants With Acquisition of Any New Antibiotic-resistant Organism
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 broad spectrum antimicrobials.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 non-ICU medical and surgical wards
- •On broad spectrum antimicrobials with an anticipated length of stay of >48 hours
排除标准
- •Pregnancy
- •Non English speaking
- •Expected to die within 7 days
- •Unable or unwilling to consent
- •HIV infection with a CD4 count <200
- •Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500)
- •Clinically significant diarrhea or history of C. difficile infection in the last 3 months
- •History of VRE colonization and/or infection in the last year
- •Transplant recipients
结局指标
主要结局
Number of Participants With Acquisition of Any New Antibiotic-resistant Organism
时间窗: Outcome will be measured approximately every 3 days after enrollment throughout hospitalization, and at the time of discharge (the median duration of hospitalization was 13.5 days).
Acquisition in the gastrointestinal tract of any new antibiotic resistant organism post-enrollment. Antibiotic resistant organisms include: C. difficile, vancomycin-resistant enterococci (VRE), multidrug-resistant Acinetobacter baumannii, multidrug-resistant Pseudomonas, ciprofloxacin-resistant Enterobacteriaceae, extended-spectrum betalactamase (ESBL) producing Enterobacteriaceae.
次要结局
未报告次要终点