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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:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256087
First received: November 17, 2005
Last updated: November 18, 2015
Last verified: April 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 17, 2005
Last Updated: November 18, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on September 26, 2016