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Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

Primary Purpose

Pneumonia, Ventilator Associated Pneumonia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lactobacillus GG

placebo

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring pneumonia, ventilator associated pneumonia, probiotics, Lactobacillus GG

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Creighton University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Lactobacillus

placebo

Outcomes

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.

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.

Full Information

NCT ID

NCT00613795

First Posted

January 31, 2008

Last Updated

March 17, 2010

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT00613795

Brief Title

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

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Ventilator Associated Pneumonia

Keywords

pneumonia, ventilator associated pneumonia, probiotics, Lactobacillus GG

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Lactobacillus

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus GG

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

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 Outcome Measure Information:

Title

Time Frame

daily while intubated

Secondary Outcome Measure Information:

Title

Time Frame

daily while intubated

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lee Morrow, MD

Organizational Affiliation

Assistant Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

81991

Citation

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Citation

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Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

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