Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

Creighton University

Status and phase: Completed; Phase 3

Conditions: Ventilator Associated Pneumonia; Pneumonia

Treatments: Dietary Supplement: placebo; Dietary Supplement: Lactobacillus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT00613795

03-13013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Lactobacillus

Treatment:

Dietary Supplement: Lactobacillus GG

2

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: placebo