Critical Illness Clinical Trial
Official title:
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.
The patients are randomised to one of three treatment groups. Each comprising of 100
patients.
1. 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.
2. 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.
3. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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