Lcr35 / ICU / P. Aeruginosa

Study Overview
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Brief Summary
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Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.

Detailed Description
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In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.

Official Title
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Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients

Conditions
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Pseudomonas Infections

Intervention / Treatment
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* Drug: Probiotic Lactobacillus casei rhamnosus (Lcr35)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 years old length of stay longer than 48h with a nasogastric feeding tube Exclusion Criteria: - less than 18 years old length of stay < 48h immunosuppression absolute neutrophile count < 500/mm3 gastro-intestinal bleeding contraindicated enteral feeding positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Probiotic Lactobacillus casei rhamnosus (Lcr35)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in P.aeruginosa colonisation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Pseudomonas aeruginosa, Gastric colonization, Respiratory tract colonization, Ventilator aquired pneumoniae, determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa