Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613795
• Other study ID #: 03-13013
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2008
• Last updated: March 17, 2010
• Start date: August 2004
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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
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

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

References & Publications (14)

Atherton ST, White DJ. Stomach as source of bacteria colonising respiratory tract during artificial ventilation. Lancet. 1978 Nov 4;2(8097):968-9. — View Citation

Ben-Menachem T, Fogel R, Patel RV, Touchette M, Zarowitz BJ, Hadzijahic N, Divine G, Verter J, Bresalier RS. Prophylaxis for stress-related gastric hemorrhage in the medical intensive care unit. A randomized, controlled, single-blind study. Ann Intern Med. 1994 Oct 15;121(8):568-75. — View Citation

Bengmark S, Gianotti L. Nutritional support to prevent and treat multiple organ failure. World J Surg. 1996 May;20(4):474-81. Review. — View Citation

Craven DE, Steger KA, Barber TW. Preventing nosocomial pneumonia: state of the art and perspectives for the 1990s. Am J Med. 1991 Sep 16;91(3B):44S-53S. Review. — View Citation

Fagon JY, Chastre J, Hance AJ, Montravers P, Novara A, Gibert C. Nosocomial pneumonia in ventilated patients: a cohort study evaluating attributable mortality and hospital stay. Am J Med. 1993 Mar;94(3):281-8. — View Citation

Hatakka K, Savilahti E, Pönkä A, Meurman JH, Poussa T, Näse L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. — View Citation

Holzapfel WH, Haberer P, Geisen R, Björkroth J, Schillinger U. Taxonomy and important features of probiotic microorganisms in food and nutrition. Am J Clin Nutr. 2001 Feb;73(2 Suppl):365S-373S. Review. — View Citation

Isolauri E. Probiotics in human disease. Am J Clin Nutr. 2001 Jun;73(6):1142S-1146S. Review. — View Citation

Johanson WG Jr, Pierce AK, Sanford JP, Thomas GD. Nosocomial respiratory infections with gram-negative bacilli. The significance of colonization of the respiratory tract. Ann Intern Med. 1972 Nov;77(5):701-6. — View Citation

Johanson WG Jr, Seidenfeld JJ, de los Santos R, Coalson JJ, Gomez P. Prevention of nosocomial pneumonia using topical and parenteral antimicrobial agents. Am Rev Respir Dis. 1988 Feb;137(2):265-72. — View Citation

Johanson WG, Pierce AK, Sanford JP. Changing pharyngeal bacterial flora of hospitalized patients. Emergence of gram-negative bacilli. N Engl J Med. 1969 Nov 20;281(21):1137-40. — View Citation

Rayes N, Seehofer D, Hansen S, Boucsein K, Müller AR, Serke S, Bengmark S, Neuhaus P. Early enteral supply of lactobacillus and fiber versus selective bowel decontamination: a controlled trial in liver transplant recipients. Transplantation. 2002 Jul 15;74(1):123-7. — View Citation

Saavedra JM. Clinical applications of probiotic agents. Am J Clin Nutr. 2001 Jun;73(6):1147S-1151S. Review. — View Citation

Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		daily while intubated	No
Secondary	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.		daily while intubated	No