Clinical trial NCT02558192: Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nosocomial Infection
Keywords: LGG
Probiotics
nosocomial infection prevention
pediatrics
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Study the incidence of nosocomial gastrointestinal infection
timeFrame: After 15 days of treatment
measure: Study the incidence of nosocomial URTI
timeFrame: After 15 days of treatment
Secondary outcomes:
measure: Days of hospitalization
timeFrame: After 3 months from the enrollment
measure: The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period
timeFrame: After 3 months from the treatment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Univesità degli Studi di Napoli "Federico II"
name: Alfredo Guarino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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