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

NCT00256087 | Completed

• 1 other identifier: 2004.067
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Nosocomial rates in critically ill patients

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (2)

• To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli.

  28 Days

• To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli.

  28 days

Study Arms (3)

Standard Care

PLACEBO COMPARATOR

Two capsules containing placebo will be given 12 hourly

Other: Lactose Powder

First active treatment

ACTIVE COMPARATOR

Two capsules containing probiotic lactobacillus fermentin given 12 hourly

Drug: Probiotic Lactobacillus

Second active reatment

ACTIVE COMPARATOR

Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly

Drug: Probiotic Lactobacillus

Interventions

Probiotic Lactobacillus DRUG

First active treatment; Second active reatment

Lactose Powder OTHER

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours.
• Patients who are commenced on enteral feeding via gastric or post pyloric routes.

You may not qualify if:

• Patients less than 18 years old.
• Patients who are already receiving probiotic treatment.
• 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.
• 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.
• Patients with a contra-indication to enteral feeding.
• Patients with contra-indication to placement of enteral feeding tube.
• Patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Intensive Care Unit Royal Melbourne Hospital Grattan Street

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Robertson

  Intensive Care Unit, Royal Melbourne Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 20, 2015

Record last verified: 2015-04

Locations

AU (1)