The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients|
- To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients. [ Time Frame: 28 days ]
- To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli. [ Time Frame: 28 Days ]
- To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli. [ Time Frame: 28 days ]
|Study Start Date:||January 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Standard Care
Two capsules containing placebo will be given 12 hourly
|Other: Lactose Powder|
Active Comparator: First active treatment
Two capsules containing probiotic lactobacillus fermentin given 12 hourly
|Drug: Probiotic Lactobacillus|
Active Comparator: Second active reatment
Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly
|Drug: Probiotic Lactobacillus|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256087
|Intensive Care Unit Royal Melbourne Hospital Grattan Street|
|Parkville, Victoria, Australia, 3050|
|Principal Investigator:||Megan Robertson||Intensive Care Unit, Royal Melbourne Hospital|