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.
Status | Completed |
Enrollment | 57 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours. 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: 1. Patients less than 18 years old. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Intensive Care Unit Royal Melbourne Hospital Grattan Street | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
Melbourne Health |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients. | 28 days | ||
Secondary | To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli. | 28 Days | ||
Secondary | To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli. | 28 days |
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