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

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT02558192

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infection	Dietary Supplement: Lactobacillus Rhamnosus GG Dietary Supplement: PLACEBO	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Probiotics

Vials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc

Dietary Supplement: Lactobacillus Rhamnosus GG

1 vials q12 for 15 days

Other Names:

LGG

Placebo Comparator: Placebo

Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor.

Dietary Supplement: PLACEBO

1 vials q12 for 15 days

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 5 Years

Sexes Eligible for Study:

All

Accepts 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)