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

Federico II University

Status and phase

Completed

Phase 3

Conditions

Nosocomial Infection

Treatments

Dietary Supplement: PLACEBO

Dietary Supplement: Lactobacillus Rhamnosus GG

Study type

Interventional

Funder types

Other

Identifiers

NCT02558192

IN001

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

3 months to 5 years old

Volunteers

No Healthy Volunteers

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)