PneumoniaPhase 3NCT00613795

Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia

A Phase 3 study testing Lactobacillus GG in people with Pneumonia and Ventilator Associated Pneumonia, run by Creighton University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Pneumonia, Ventilator Associated Pneumonia
What is being tested?: Lactobacillus GG
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 1 siteUnited States
Study dates: Aug 2004to Nov 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Creighton University Medical Center
Omaha, Nebraska, 68131

Other trials in United States

About this study

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

Read the 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.

Conditions: Pneumonia, Ventilator Associated Pneumonia
Being tested: Lactobacillus GG, placebo
Keywords: pneumonia, ventilator associated pneumonia, probiotics, Lactobacillus GG
Medical subject headings: Pneumonia, Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lactobacillus GGDietary 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.
placeboDietary 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

Study groups in NCT00613795
Study group	Role	What they receive
1	Active comparator	Lactobacillus Receives: Dietary Supplement: Lactobacillus GG
2	Placebo comparator	placebo Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: daily while intubated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2004Nov 2009

First posted13 Feb 2008 (estimated)
Study startAug 2004
Primary completionAug 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 125 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613795
Sponsor's protocol ID: 03-13013
Status last verified: Mar 2010
First submitted: 31 Jan 2008
Last updated: 18 Mar 2010
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 81991
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.
PubMed 8085688
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.
PubMed 8662138
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.
PubMed 1928191
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.
PubMed 11387176
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.
PubMed 8452152
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.
PubMed 11157343
Isolauri E. Probiotics in human disease. Am J Clin Nutr. 2001 Jun;73(6):1142S-1146S. doi: 10.1093/ajcn/73.6.1142S.
PubMed 11393192
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.
PubMed 4899868
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.
PubMed 5081492
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.
PubMed 3341620
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.
PubMed 12134110
Saavedra JM. Clinical applications of probiotic agents. Am J Clin Nutr. 2001 Jun;73(6):1147S-1151S. doi: 10.1093/ajcn/73.6.1147S.
PubMed 11393193
Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. doi: 10.1093/ajcn/73.6.1152S.
PubMed 11393194
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.
PubMed 20522788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lactobacillus GG in the Prophylaxis of Ventilator Associated Pneumonia: A Prospective, Randomized, Placebo-controlled, Double-blind Study
ClinicalTrials.gov ID: NCT00613795
Acronym / sponsor ID: 03-13013
Conditions: Pneumonia, Ventilator Associated Pneumonia
Keywords: pneumonia, ventilator associated pneumonia, probiotics, Lactobacillus GG
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (estimated)
Lead sponsor: Creighton UniversityUniversity, hospital or other
Study start: Aug 2004
Primary completion: Aug 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Dietary Supplement: Lactobacillus GGLactobacillus
2	Placebo comparator	Dietary Supplement: placeboplacebo

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lactobacillus GGEvery 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.	Dietary supplement	1
placeboEvery 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	Dietary supplement	2

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
Background: PubMed 81991Atherton 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.
Background: PubMed 8085688Ben-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.
Background: PubMed 8662138Bengmark 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.
Background: PubMed 1928191Craven 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.
Background: PubMed 11387176Hatakka 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.
Background: PubMed 8452152Fagon 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.
Background: PubMed 11157343Holzapfel 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.
Background: PubMed 11393192Isolauri E. Probiotics in human disease. Am J Clin Nutr. 2001 Jun;73(6):1142S-1146S. doi: 10.1093/ajcn/73.6.1142S.
Background: PubMed 4899868Johanson 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.
Background: PubMed 5081492Johanson 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.
Background: PubMed 3341620Johanson 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.
Background: PubMed 12134110Rayes 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lee Morrow, MD principal investigator

Assistant Professor of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lactobacillus GG in people with Pneumonia and Ventilator Associated Pneumonia, run by Creighton University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613795, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010.