Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

Study Overview
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Brief Summary
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Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.

Conditions
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Nosocomial Infection

Intervention / Treatment
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* Dietary Supplement: Lactobacillus Rhamnosus GG
* Dietary Supplement: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between the ages of 3 months and 5 years Children admitted to a pediatric ward Exclusion Criteria: Children with chronic diseases of the respiratory , gastrointestinal , renal system; Children with malformations of the cardiovascular system ; Children with immune deficiencies ; Infants born preterm ( gestational age < 37 weeks ) ; Children with congenital metabolic diseases ; Children Who received probiotics before enrollment ( up to 7 days before hospitalization)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Vials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc | Dietary Supplement: Lactobacillus Rhamnosus GG<br>* 1 vials q12 for 15 days<br>* Other names: LGG;|
| Placebo Comparator: Placebo<br>Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor. | Dietary Supplement: PLACEBO<br>* 1 vials q12 for 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the incidence of nosocomial gastrointestinal infection |  | After 15 days of treatment | 
| Study the incidence of nosocomial URTI |  | After 15 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of hospitalization |  | After 3 months from the enrollment | 
| The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period |  | After 3 months from the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LGG, Probiotics, nosocomial infection prevention, pediatrics