Clinical trial NCT00613795: Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia
Official title: Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia: A Prospective, Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Ventilator Associated Pneumonia
Keywords: pneumonia
ventilator associated pneumonia
probiotics
Lactobacillus GG
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 125
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: 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.
timeFrame: daily while intubated
Secondary outcomes:
measure: 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.
timeFrame: daily while intubated
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Assistant Professor of Medicine
name: Lee Morrow, MD
role: PRINCIPAL_INVESTIGATOR
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