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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02558192
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):
Alfredo Guarino, Federico II University

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

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 Name: 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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02558192

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University of Naples "Federico II"
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
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Principal Investigator: Alfredo Guarino, MD Univesità degli Studi di Napoli "Federico II"


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Responsible Party: Alfredo Guarino, Full Professor of Pediatrics, Federico II University Identifier: NCT02558192     History of Changes
Other Study ID Numbers: IN001
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Alfredo Guarino, Federico II University:
nosocomial infection prevention

Additional relevant MeSH terms:
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Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes