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

September 22, 2015 updated by: Alfredo Guarino, Federico II University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Alfredo Guarino, MD, Univesità degli Studi di Napoli "Federico II"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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