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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256087
First Posted: November 21, 2005
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Melbourne Health
  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 Other: Lactose Powder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

Resource links provided by NLM:


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 ]

Enrollment: 57
Study Start Date: January 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard Care
Two capsules containing placebo will be given 12 hourly
Other: Lactose Powder
Active Comparator: First active treatment
Two capsules containing probiotic lactobacillus fermentin given 12 hourly
Drug: Probiotic Lactobacillus
Active Comparator: Second active reatment
Two capsules containing probiotic lactobacillus acidiphilus given 12 hourly
Drug: Probiotic Lactobacillus

Detailed 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256087


Locations
Australia, Victoria
Intensive Care Unit Royal Melbourne Hospital Grattan Street
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Megan Robertson Intensive Care Unit, Royal Melbourne Hospital
  More Information

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00256087     History of Changes
Other Study ID Numbers: 2004.067
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: November 20, 2015
Last Verified: April 2015

Keywords provided by Melbourne Health:
Nosocomial rates in critically ill patients

Additional relevant MeSH terms:
Pneumonia
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes