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

Primary Purpose

Nosocomial Infection

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus Rhamnosus GG
PLACEBO
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring LGG, Probiotics, nosocomial infection prevention, pediatrics

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • University of Naples "Federico II"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Study the incidence of nosocomial gastrointestinal infection
Study the incidence of nosocomial URTI

Secondary Outcome Measures

Days of hospitalization
The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period

Full Information

First Posted
April 13, 2015
Last Updated
September 22, 2015
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02558192
Brief Title
Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection
Keywords
LGG, Probiotics, nosocomial infection prevention, pediatrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Vials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus Rhamnosus GG
Other Intervention Name(s)
LGG
Intervention Description
1 vials q12 for 15 days
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
1 vials q12 for 15 days
Primary Outcome Measure Information:
Title
Study the incidence of nosocomial gastrointestinal infection
Time Frame
After 15 days of treatment
Title
Study the incidence of nosocomial URTI
Time Frame
After 15 days of treatment
Secondary Outcome Measure Information:
Title
Days of hospitalization
Time Frame
After 3 months from the enrollment
Title
The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period
Time Frame
After 3 months from the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Guarino, MD
Organizational Affiliation
Univesità degli Studi di Napoli "Federico II"
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Naples "Federico II"
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20403940
Citation
Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
Results Reference
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PubMed Identifier
16673007
Citation
Guarner F, Bourdet-Sicard R, Brandtzaeg P, Gill HS, McGuirk P, van Eden W, Versalovic J, Weinstock JV, Rook GA. Mechanisms of disease: the hygiene hypothesis revisited. Nat Clin Pract Gastroenterol Hepatol. 2006 May;3(5):275-84. doi: 10.1038/ncpgasthep0471.
Results Reference
background
PubMed Identifier
18479259
Citation
Packey CD, Sartor RB. Interplay of commensal and pathogenic bacteria, genetic mutations, and immunoregulatory defects in the pathogenesis of inflammatory bowel diseases. J Intern Med. 2008 Jun;263(6):597-606. doi: 10.1111/j.1365-2796.2008.01962.x.
Results Reference
background
PubMed Identifier
15173836
Citation
Macpherson AJ, Harris NL. Interactions between commensal intestinal bacteria and the immune system. Nat Rev Immunol. 2004 Jun;4(6):478-85. doi: 10.1038/nri1373. No abstract available.
Results Reference
background
PubMed Identifier
17024229
Citation
Mazmanian SK, Kasper DL. The love-hate relationship between bacterial polysaccharides and the host immune system. Nat Rev Immunol. 2006 Nov;6(11):849-58. doi: 10.1038/nri1956. Epub 2006 Oct 6.
Results Reference
background
PubMed Identifier
16168782
Citation
Brooks WA, Santosham M, Naheed A, Goswami D, Wahed MA, Diener-West M, Faruque AS, Black RE. Effect of weekly zinc supplements on incidence of pneumonia and diarrhoea in children younger than 2 years in an urban, low-income population in Bangladesh: randomised controlled trial. Lancet. 2005 Sep 17-23;366(9490):999-1004. doi: 10.1016/S0140-6736(05)67109-7.
Results Reference
background
PubMed Identifier
7651474
Citation
Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. doi: 10.1056/NEJM199509283331304.
Results Reference
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Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

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