The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT00256087|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : November 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Drug: Probiotic Lactobacillus Other: Lactose Powder||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256087
|Intensive Care Unit Royal Melbourne Hospital Grattan Street|
|Parkville, Victoria, Australia, 3050|
|Principal Investigator:||Megan Robertson||Intensive Care Unit, Royal Melbourne Hospital|