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Completed

NCT Number: NCT00613795

Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus GG

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia: A Prospective, Randomized, Placebo-controlled, Double-blind Study

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2008
Registry last updated
Mar 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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