The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.
研究概览
简要总结
To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients.
The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.
The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli.
详细描述
The patients are randomised to one of three treatment groups. Each comprising of 100 patients.
- Standard therapy group. Patients will receive enteral feeding (with fibre) aiming at the target feeding rate that is determined by the treating physician and the ICU dietician, as is standard current practice. Two capsule containing placebo will be given 12 hourly via the feeding tube.
- The first active treatment group, will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentum included in the feeding regime. Two capsules containing Lactobacillus fermentum (10 11 organisms per capsule) will be delivered via the feeding tube 12 hourly.
- The second active treatment group will receive enteral feeding (with fibre) plus the probiotic Lactobacillus acidophilus included in the feeding regime. Two capsules containing Lactobacillus acidophilus (2x10 9 organisms per capsule) will be delivered via the feeding tube 12 hourly.
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
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
- •Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours.
- •Patients who are commenced on enteral feeding via gastric or post pyloric routes.
- •Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study
排除标准
- •Patients less than 18 years old.
- •Patients who are already receiving probiotic treatment.
- •The lactobacillus acidophilus preparation to be used in the study, contains a very small amount of MSG (total dose of 20mg/day, equivalent to 10% of the initial dose used to test MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded.
- •Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As the Lactobacillus is a live micro-organism, immunosuppressed and pregnant pateints will be excluded.
- •Patients with a contra-indication to enteral feeding.
- •Patients with contra-indication to placement of enteral feeding tube.
- •Patients or next-of-kin who do not consent to inclusion in the study.
- •Patients who are already enrolled in another study that may influence the outcome of the probiotic study.
研究组 & 干预措施
Standard Care
Two capsules containing placebo will be given 12 hourly
干预措施: Lactose Powder (Other)
First active treatment
Two capsules containing probiotic lactobacillus fermentin given 12 hourly
干预措施: Probiotic Lactobacillus (Drug)
Second active reatment
Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly
干预措施: Probiotic Lactobacillus (Drug)
结局指标
主要结局
To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.
时间窗: 28 days
次要结局
- To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.(28 Days)
- To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.(28 days)