A Randomized Controlled Trial of Probiotics to Prevent Influenza and Other Respiratory Infections in Residents of Long-term Care Facilities: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,440
- 试验地点
- 26
- 主要终点
- laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study
研究概览
简要总结
The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection.
详细描述
The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection. The investigators will determine whether it is feasible to enroll residents and randomize them to a daily course of probiotics or placebo and monitor for influenza and other respiratory tract infections. In addition, the investigators will asses the feasibility of obtaining a nasal specimen for evaluation of the upper respiratory microbiome, measure antimicrobials, and deterioration in functional status. All aspects of the proposed trial will be assessed, including enrollment, randomization, respiratory infection surveillance, methods for outcome assessment, and event rates. The investigators will test the use of our data collection forms and data management strategy and will generate date to derive an appropriate sample size.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nursing home residents, 65 years of age or older, in the Hamilton ON area
排除标准
- •residents who are immunosuppressed (steroids or other immunosuppressives), have a hematologic malignancy, structural heart disease, gastroesophageal or intestinal injury and those are at increased risk of an endovascular infection will be excluded
研究组 & 干预措施
Probiotics
Participants randomized to probiotics will receive 2 capsules supplemented with 10 billion cfu of Lactobacillus rhamnosus GG on a daily basis for six months
干预措施: Probiotics (Dietary Supplement)
Probiotic placebo
Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months
干预措施: probiotic placebo (Other)
结局指标
主要结局
laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study
时间窗: Participants will be assessed twice weekly for symptoms for 6 months. This will begin after they have been randomized to probiotics or placebo arms of the study
this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR)
次要结局
- influenza like illness(Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo)
- antimicrobial prescriptions(To be reviewed at the twice weekly assessments for 6 months following randomization)
- physician visits for respiratory illness(The participant's MD patient record will be reviewed for visits during the 12 months following randomization)
- hospitalizations for lower respiratory infection or pneumonia(Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization)