Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-28 @ 11:49 AM
Study NCT ID:
NCT01702766
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-10', 'releaseDate': '2015-05-25'}, {'resetDate': '2015-11-25', 'releaseDate': '2015-10-26'}, {'resetDate': '2016-01-04', 'releaseDate': '2015-11-26'}], 'estimatedResultsFirstSubmitDate': '2015-05-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severity of infection', 'description': 'Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale'}], 'primaryOutcomes': [{'measure': 'Common infections in children', 'description': 'Number of children with common infections (gastrointestinal and respiratory infections):\n\nGastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both.\n\nRespiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.'}], 'secondaryOutcomes': [{'measure': 'Duration of symptoms', 'description': 'Duration of symptoms in days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastrointestinal Tract Infections', 'Respiratory Tract Infections']}, 'referencesModule': {'references': [{'pmid': '25733653', 'type': 'DERIVED', 'citation': 'Hojsak I, Tokic Pivac V, Mocic Pavic A, Pasini AM, Kolacek S. Bifidobacterium animalis subsp. lactis fails to prevent common infections in hospitalized children: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2015 Mar;101(3):680-4. doi: 10.3945/ajcn.114.102004. Epub 2015 Jan 7.'}]}, 'descriptionModule': {'briefSummary': "Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission\n\nThis study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.\n\nThe study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections.\n\nThe test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.\n\nThe placebo product is an identical product except for the absence of probiotics.\n\nThe study includes an intervention period lasting the length of the hospital stay.\n\nThe study product will be consumed daily in the morning together with breakfast.\n\nThe consumption of the study products will be taken under the surveillance of the physician.\n\nData on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb\n* Age from 1 year to 18 years\n* Signed informed consent by the parents\n\nExclusion Criteria:\n\n* Immunodeficiency\n* Infants from neonatal period until 1 year of age\n* Re-hospitalisation (readmission in a hospital within one month)\n* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)\n* Neoplasms\n* Severe chronic diseases\n* Hospitalization shorter than 3 days"}, 'identificationModule': {'nctId': 'NCT01702766', 'acronym': 'PROBIC II', 'briefTitle': 'Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Zagreb"}, 'orgStudyIdInfo': {'id': 'PROBBIC II Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bifidobacterium animalis subsp. lactis', 'interventionNames': ['Dietary Supplement: Bifidobacterium animalis subsp. lactis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo'}], 'interventions': [{'name': 'Bifidobacterium animalis subsp. lactis', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Bifidobacterium animalis subsp. lactis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': "Children's Hospital Zagreb", 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Zagreb", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-25', 'type': 'RELEASE'}, {'date': '2015-06-10', 'type': 'RESET'}, {'date': '2015-10-26', 'type': 'RELEASE'}, {'date': '2015-11-25', 'type': 'RESET'}, {'date': '2015-11-26', 'type': 'RELEASE'}, {'date': '2016-01-04', 'type': 'RESET'}], 'unpostedResponsibleParty': "Children's Hospital Zagreb"}}}}