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

NCT ID: NCT02558192

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Nosocomial Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Probiotics

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

Group Type: EXPERIMENTAL

Lactobacillus Rhamnosus GG

Intervention Type: DIETARY_SUPPLEMENT

1 vials q12 for 15 days

Placebo

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

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

1 vials q12 for 15 days

Interventions

Lactobacillus Rhamnosus GG

1 vials q12 for 15 days

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

1 vials q12 for 15 days

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

LGG

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)

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Guarino

Full Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfredo Guarino, MD

Role: PRINCIPAL_INVESTIGATOR

Univesità degli Studi di Napoli "Federico II"

Locations

University of Naples "Federico II"

Naples, Naples, Italy

Countries

Italy

References

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Reference Type: BACKGROUND

PMID: 20403940 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15173836 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17024229 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16168782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7651474 (View on PubMed)

Other Identifiers

IN001

Identifier Type: -

Identifier Source: org_study_id