Status:
COMPLETED
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
Lead Sponsor:
Melbourne Health
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 feedi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00256087
Start Date
January 1 2005
End Date
January 1 2010
Last Update
November 20 2015
Active Locations (1)
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1
Intensive Care Unit Royal Melbourne Hospital Grattan Street
Parkville, Victoria, Australia, 3050