Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-03 @ 2:29 PM
Study NCT ID:
NCT02558192
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2015-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2015-04-13', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study the incidence of nosocomial gastrointestinal infection', 'timeFrame': 'After 15 days of treatment'}, {'measure': 'Study the incidence of nosocomial URTI', 'timeFrame': 'After 15 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Days of hospitalization', 'timeFrame': 'After 3 months from the enrollment'}, {'measure': 'The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period', 'timeFrame': 'After 3 months from the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LGG', 'Probiotics', 'nosocomial infection prevention', 'pediatrics'], 'conditions': ['Nosocomial Infection']}, 'referencesModule': {'references': [{'pmid': '20403940', 'type': 'BACKGROUND', '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.'}, {'pmid': '16673007', 'type': 'BACKGROUND', '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.'}, {'pmid': '18479259', 'type': 'BACKGROUND', '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.'}, {'pmid': '15173836', 'type': 'BACKGROUND', '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.'}, {'pmid': '17024229', 'type': 'BACKGROUND', '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.'}, {'pmid': '16168782', 'type': 'BACKGROUND', '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.'}, {'pmid': '7651474', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between the ages of 3 months and 5 years\n* Children admitted to a pediatric ward\n\nExclusion Criteria:\n\n* Children with chronic diseases of the respiratory , gastrointestinal , renal system;\n* Children with malformations of the cardiovascular system ;\n* Children with immune deficiencies ;\n* Infants born preterm ( gestational age \\< 37 weeks ) ;\n* Children with congenital metabolic diseases ;\n* Children Who received probiotics before enrollment ( up to 7 days before hospitalization)'}, 'identificationModule': {'nctId': 'NCT02558192', 'briefTitle': 'Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'orgStudyIdInfo': {'id': 'IN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': 'Vials containing 3 x 10\\^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc', 'interventionNames': ['Dietary Supplement: Lactobacillus Rhamnosus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor.', 'interventionNames': ['Dietary Supplement: PLACEBO']}], 'interventions': [{'name': 'Lactobacillus Rhamnosus GG', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['LGG'], 'description': '1 vials q12 for 15 days', 'armGroupLabels': ['Probiotics']}, {'name': 'PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 vials q12 for 15 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Naples', 'country': 'Italy', 'facility': 'University of Naples "Federico II"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Alfredo Guarino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univesità degli Studi di Napoli "Federico II"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Pediatrics', 'investigatorFullName': 'Alfredo Guarino', 'investigatorAffiliation': 'Federico II University'}}}}