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

NCT02558192 | Completed Phase 3

• 1 other identifier: IN001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

LGG; Probiotics; nosocomial infection prevention; pediatrics

Outcome Measures

Primary Outcomes (2)

• Study the incidence of nosocomial gastrointestinal infection

  After 15 days of treatment

• Study the incidence of nosocomial URTI

  After 15 days of treatment

Secondary Outcomes (2)

• Days of hospitalization

  After 3 months from the enrollment

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

  After 3 months from the treatment

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus Rhamnosus GG

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: PLACEBO

Interventions

Lactobacillus Rhamnosus GG DIETARY_SUPPLEMENT

1 vials q12 for 15 days

Also known as: LGG

Probiotics

PLACEBO DIETARY_SUPPLEMENT

1 vials q12 for 15 days

Placebo

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females between the ages of 3 months and 5 years
• Children admitted to a pediatric ward

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, Naples, 80131, Italy

Location

Related Publications (7)

• 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.

  PMID: 20403940 BACKGROUND

• 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.

  PMID: 16673007 BACKGROUND

• 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.

  PMID: 18479259 BACKGROUND

• 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.

  PMID: 15173836 BACKGROUND

• 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.

  PMID: 17024229 BACKGROUND

• 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.

  PMID: 16168782 BACKGROUND

• 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.

  PMID: 7651474 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfredo Guarino, MD

  Univesità degli Studi di Napoli "Federico II"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pediatrics

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: September 23, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

IT (1)