The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients
NCT ID: NCT00256087
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2005-01-31
2010-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Standard Care
Two capsules containing placebo will be given 12 hourly
Lactose Powder
First active treatment
Two capsules containing probiotic lactobacillus fermentin given 12 hourly
Probiotic Lactobacillus
Second active reatment
Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly
Probiotic Lactobacillus
Interventions
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Probiotic Lactobacillus
Lactose Powder
Eligibility Criteria
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Inclusion Criteria
2. Patients who are commenced on enteral feeding via gastric or post pyloric routes.
3. Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study
Exclusion Criteria
2. Patients who are already receiving probiotic treatment.
3. 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.
4. 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.
5. Patients with a contra-indication to enteral feeding.
6. Patients with contra-indication to placement of enteral feeding tube.
7. Patients or next-of-kin who do not consent to inclusion in the study.
8. Patients who are already enrolled in another study that may influence the outcome of the probiotic study.
18 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Responsible Party
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Principal Investigators
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Megan Robertson
Role: PRINCIPAL_INVESTIGATOR
Intensive Care Unit, Royal Melbourne Hospital
Locations
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Intensive Care Unit Royal Melbourne Hospital Grattan Street
Parkville, Victoria, Australia
Countries
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Other Identifiers
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2004.067
Identifier Type: -
Identifier Source: org_study_id