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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256087
• Other study ID #: 2004.067
• Status: Completed
• Phase: N/A
• First received: November 17, 2005
• Last updated: November 18, 2015
• Start date: January 2005
• Est. completion date: January 2010

Study information

• Verified date: April 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Pneumonia

Intervention

Drug:
• Probiotic Lactobacillus

Other:
• Lactose Powder

Locations

Country	Name	City	State
Australia	Intensive Care Unit Royal Melbourne Hospital Grattan Street	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

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