Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00613795
First received: January 31, 2008
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

This study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and stomach, via feeding tube, in effort to determine whether the oral administration of a naturally occurring Lactobacillus species reduces the incidence of ventilator associated pneumonia therefore reducing intensive care unit(ICU)complications.


Condition Intervention Phase
Pneumonia
Ventilator Associated Pneumonia
Dietary Supplement: Lactobacillus GG
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia: A Prospective, Randomized, Placebo-controlled, Double-blind Study

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • To determine whether patients given oral Lactobacillus GG will have a smaller increase in the density of pathogenic bacterial in cultures from oral swabs, nasogastric aspirates, and minimally invasive bronchoalveolar lavage samples. [ Time Frame: daily while intubated ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess whether administration of Lactobacillus GG to intubated patients reduces clinically diagnosed VAP,reduces microbiologically diagnosed VAP, affects mortality and duration of mechanical ventilation, and total antibiotic consumption. [ Time Frame: daily while intubated ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: August 2004
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Lactobacillus
Dietary Supplement: Lactobacillus GG
Every 12 hours, the contents of a single capsule containing Lactobacillus GG will be suspended in 3 ml of water-soluble jelly. The suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second capsule will be suspended in 10 ml of sterile water and pushed through the NG tub followed by 10 mL of air to ensure complete administration.
Placebo Comparator: 2
placebo
Dietary Supplement: placebo
Every 12 hours, the contents of a single identical placebo capsule containing the inert plant carbohydrate inulin will be suspended in 3 ml of water-soluble jelly. This suspension will be applied to the oropharyngeal mucosa via sterile syringe. The contents of a second placebo capsule will be suspended in 10 ml of sterile water and pushed through eh NG tube followed by 10 mL of air to ensure complete administration

Detailed Description:

The long-term objective of this research is to determine the utility of altering the oral and gastric bacterial flora in mechanically ventilated patients in order to reduce intensive care unit (ICU)complications. Specifically, our goal is to determine whether the oral administration of a naturally occurring Lactobacillus species reduces the incidence of ventilator associated pneumonia (VAP). ICU admission is commonly accompanied by overgrowth of the natural gastrointestinal (GI) and oropharyngeal flor by pathogenic organisms. Patients requiring endotracheal intubation are predisposed to developing VAP, presumably via micro-aspiration of the altered oropharyngeal flora. By reducing VAP rates, we hope to improve ICU outcomes, minimize ICU expenses, and most importantly, decrease morbidity and mortality.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission to the medical, surgical, or cardiac ICU
  • Age 19 years or greater (the age of majority in the state of Nebraska)
  • Anticipated need for >72 hours of endotracheal intubation
  • Initial intubation during hospitalization
  • Approval of the attending physician responsible for the patient's care
  • Informed surrogate consent within 24 hours of intubation

Exclusion Criteria:

  • Pregnancy
  • Pharmacologic immunosuppression (>10mg prednisone daily or equivalent for at least 14 days)
  • Native immunosuppression: 1)known HIV disease or AIDS, 2)history of malignancy, 3)multiple organ system failure
  • History of prosthetic or bioprosthetic cardiac valve placement
  • History of prosthetic vascular graft placement
  • Cardiac trauma
  • History of rheumatic fever, endocarditis, congenital cardia abnormality, or acquired cardia abnormality
  • Gastroesophageal surgery or perforation associated with current admission
  • Intestinal surgery or perforation associated with current admission
  • Significant oropharyngeal mucosal injury
  • Placement of a tracheostomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613795

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Lee Morrow, MD Assistant Professor of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee Morrow, MD, Creighton University Medical Center
ClinicalTrials.gov Identifier: NCT00613795     History of Changes
Other Study ID Numbers: 03-13013
Study First Received: January 31, 2008
Last Updated: March 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
pneumonia
ventilator associated pneumonia
probiotics
Lactobacillus GG

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on April 17, 2014