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

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Probiotic Lactobacillus

Other:Lactose Powder

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard CareTwo capsules containing placebo will be given 12 hourly

First active treatmentTwo capsules containing probiotic lactobacillus fermentin given 12 hourly

Second active reatmentTwo capsules containing probiotic lactobacillus acidiphilus given 12 hourly

Study Status

Completed

Start Date: January 2005

Completed Date: January 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients.

Secondary Outcome: To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.

Study sponsors, principal investigator, and references

Principal Investigator: Megan Robertson

Lead Sponsor: Melbourne Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00256087

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