Overview

The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Melbourne Health
Criteria
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.