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

Nosocomial Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558192
• Other study ID #: IN001
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2015
• Last updated: September 22, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• Infection
• Nosocomial Infection

Intervention

Dietary Supplement:
• Lactobacillus Rhamnosus GG
1 vials q12 for 15 days
• PLACEBO
1 vials q12 for 15 days

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. Review. — View 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. — View Citation

Macpherson AJ, Harris NL. Interactions between commensal intestinal bacteria and the immune system. Nat Rev Immunol. 2004 Jun;4(6):478-85. — View 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. Epub 2006 Oct 6. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the incidence of nosocomial gastrointestinal infection		After 15 days of treatment	No
Primary	Study the incidence of nosocomial URTI		After 15 days of treatment	No
Secondary	Days of hospitalization		After 3 months from the enrollment	No
Secondary	The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period		After 3 months from the treatment	No