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OpenTrials
Completed

NCT Number: NCT02558192

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

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.

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Key information

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Naples "Federico II"

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

1 vials q12 for 15 days

Other names: LGG

Placebo

Dietary Supplement

1 vials q12 for 15 days

Primary outcomes

  1. Study the incidence of nosocomial gastrointestinal infection

    Time frame: After 15 days of treatment

  2. Study the incidence of nosocomial URTI

    Time frame: After 15 days of treatment

Secondary outcomes

  1. Days of hospitalization

    Time frame: After 3 months from the enrollment

  2. The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period

    Time frame: After 3 months from the treatment

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 23, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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