Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

NCT00613795 | Completed Phase 3

• 1 other identifier: 03-13013
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Ventilator Associated Pneumonia

Keywords

pneumonia; ventilator associated pneumonia; probiotics; Lactobacillus GG

Outcome Measures

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.

  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.

  daily while intubated

Study Arms (2)

1

ACTIVE COMPARATOR

Lactobacillus

Dietary Supplement: Lactobacillus GG

2

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

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.

1

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

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (15)

• Atherton ST, White DJ. Stomach as source of bacteria colonising respiratory tract during artificial ventilation. Lancet. 1978 Nov 4;2(8097):968-9. doi: 10.1016/s0140-6736(78)92530-8.

  PMID: 81991 BACKGROUND

• 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. doi: 10.7326/0003-4819-121-8-199410150-00003.

  PMID: 8085688 BACKGROUND

• Bengmark S, Gianotti L. Nutritional support to prevent and treat multiple organ failure. World J Surg. 1996 May;20(4):474-81. doi: 10.1007/s002689900075.

  PMID: 8662138 BACKGROUND

• 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. doi: 10.1016/0002-9343(91)90343-v.

  PMID: 1928191 BACKGROUND

• Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase 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. doi: 10.1136/bmj.322.7298.1327.

  PMID: 11387176 BACKGROUND

• 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. doi: 10.1016/0002-9343(93)90060-3.

  PMID: 8452152 BACKGROUND

• Holzapfel WH, Haberer P, Geisen R, Bjorkroth 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. doi: 10.1093/ajcn/73.2.365s.

  PMID: 11157343 BACKGROUND

• Isolauri E. Probiotics in human disease. Am J Clin Nutr. 2001 Jun;73(6):1142S-1146S. doi: 10.1093/ajcn/73.6.1142S.

  PMID: 11393192 BACKGROUND

• 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. doi: 10.1056/NEJM196911202812101. No abstract available.

  PMID: 4899868 BACKGROUND

• 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. doi: 10.7326/0003-4819-77-5-701. No abstract available.

  PMID: 5081492 BACKGROUND

• 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. doi: 10.1164/ajrccm/137.2.265.

  PMID: 3341620 BACKGROUND

• Rayes N, Seehofer D, Hansen S, Boucsein K, Muller 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. doi: 10.1097/00007890-200207150-00021.

  PMID: 12134110 BACKGROUND

• Saavedra JM. Clinical applications of probiotic agents. Am J Clin Nutr. 2001 Jun;73(6):1147S-1151S. doi: 10.1093/ajcn/73.6.1147S.

  PMID: 11393193 BACKGROUND

• Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. doi: 10.1093/ajcn/73.6.1152S.

  PMID: 11393194 BACKGROUND

• Morrow LE, Kollef MH, Casale TB. Probiotic prophylaxis of ventilator-associated pneumonia: a blinded, randomized, controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1058-64. doi: 10.1164/rccm.200912-1853OC. Epub 2010 Jun 3.

  PMID: 20522788 DERIVED

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lee Morrow, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: August 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

US (1)