CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 target
Drug / intervention
Lactobacillus GG +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00613795
NCT00613795Phase 3Completed

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

Creighton University·interventional·Posted Feb 13, 2008·Updated Mar 18, 2010

In Brief

A Phase 3 clinical trial evaluating Lactobacillus GG and placebo for Pneumonia and Ventilator Associated Pneumonia. Completed, enrolled 125 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartAug 1, 2004
Primary CompletionAug 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.4 years ago

Interventions

Lactobacillus GGdietary

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

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