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

Sponsored by:	Melbourne Health
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00256087

Purpose

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.

Condition	Intervention
Critical Illness	Drug: Probiotic Lactobacillus

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients. [ Time Frame: 28 days ]

Secondary Outcome Measures:

To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli. [ Time Frame: 28 Days ]
To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli. [ Time Frame: 28 days ]

Estimated Enrollment:	300
Study Start Date:	January 2005

Detailed Description:

The patients are randomised to one of three treatment groups. Each comprising of 100 patients.

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.
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study

Exclusion Criteria:

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 or next-of-kin who do not consent to inclusion in the study.
Patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256087

Contacts

Contact: Megan Robertson	61 3 93427441	megan.robertson@mh.org.au
Contact: Deborah Barge	61 3 93427710	deborah.barge@mh.org.au

Locations

Australia, Victoria
Intensive Care Unit Royal Melbourne Hospital Grattan Street	Recruiting
Parkville, Victoria, Australia, 3050
Contact: Megan Robertson 61 3 93427441 megan.robertson@mh.org.au
Principal Investigator: Megan Robertson
Sub-Investigator: John F Cade
Sub-Investigator: Julian Hunt-Smith

Sponsors and Collaborators

Melbourne Health

Investigators

Principal Investigator:

Megan Robertson

Intensive Care Unit, Royal Melbourne Hospital

More Information

No publications provided

Study ID Numbers:	2004.067
Study First Received:	November 17, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00256087 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:

Nosocomial rates in critically ill patients

Study placed in the following topic categories:

Critical Illness
Pneumonia

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Critical Illness

ClinicalTrials.gov processed this record on May 07, 2009