{ "FullStudy":{ "Rank":218238, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510938", "OrgStudyIdInfo":{ "OrgStudyId":"SG-11009" }, "Organization":{ "OrgFullName":"Lviv National Medical University", "OrgClass":"OTHER" }, "BriefTitle":"Probiotics in Respiratory Tract Infections in Children", "OfficialTitle":"Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children" }, "StatusModule":{ "StatusVerifiedDate":"December 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 25, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 30, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Sergei V. Gerasimov, MD, PhD", "ResponsiblePartyInvestigatorTitle":"Associate Professor of Pediatrics", "ResponsiblePartyInvestigatorAffiliation":"Lviv National Medical University" }, "LeadSponsor":{ "LeadSponsorName":"Lviv National Medical University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Infections, Respiratory Tract" ] }, "KeywordList":{ "Keyword":[ "Children", "Respiratory Tract Infections", "Prevention" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"242", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Placebo" ] } },{ "ArmGroupLabel":"Probiotic", "ArmGroupType":"Experimental", "ArmGroupDescription":"powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide\n\n1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"L. acidophilus DDS-1, B. lactis UABLA-12", "InterventionDescription":"1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Probiotic" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "DDS-Junior" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"Placebo", "InterventionDescription":"1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Rice maltodextrin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Incidence of respiratory tract infection episodes in a child", "PrimaryOutcomeDescription":"An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours", "PrimaryOutcomeTimeFrame":"1 month" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Duration of respiratory tract infection", "SecondaryOutcomeDescription":"Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Severity of respiratory tract infection", "SecondaryOutcomeDescription":"a product of daily CARIFS times the duration of the disease", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Complications of respiratory tract infections", "SecondaryOutcomeDescription":"Percent of otitis, sinusitis, bronchitis, pneumonia cases", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Antibiotic prescriptions", "SecondaryOutcomeDescription":"Percent", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Hospitalization rate", "SecondaryOutcomeDescription":"Number of hospitalizations", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Number of unscheduled doctor visits", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Number of days daycare/school missed", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Number of workdays missed by parents", "SecondaryOutcomeTimeFrame":"21 days" },{ "SecondaryOutcomeMeasure":"Time to resolution of individual CARIFS item", "SecondaryOutcomeDescription":"Days to the correspondent CARIFS item 0", "SecondaryOutcomeTimeFrame":"21" },{ "SecondaryOutcomeMeasure":"25% and 50% decrease in the CARIFS score", "SecondaryOutcomeDescription":"25% and 50% decrease in the CARIFS score", "SecondaryOutcomeTimeFrame":"21day" },{ "SecondaryOutcomeMeasure":"Percent and duration of the use of over-the-counter medications", "SecondaryOutcomeDescription":"Percent and duration of the use of over-the-counter medications", "SecondaryOutcomeTimeFrame":"21day" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge 3-12 yrs\nAt least one episode of respiratory tract infection in the previous epidemiological season\nDirect telephone access available\nInformed consent signed\n\nExclusion Criteria:\n\nVaccination against the influenza\nChronic adeno-tonsillar pathology\nRecurrent otitis\nSinusitis\nRespiratory allergy\nAcute or chronic intestinal disease with diarrhea and/or malabsorption syndrome\nLactose intolerance\nFunctional or organic constipation\nDown syndrome\nCongenital or acquired heart disease\nCerebral palsy\nAny chronic hepatic, renal, metabolic, or immune system disease", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"3 Years", "MaximumAge":"12 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sergei V Gerasimov, M.D., Ph.D.", "OverallOfficialAffiliation":"Lviv National Medical University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Lviv City Children Hospital", "LocationCity":"Lviv", "LocationZip":"79059", "LocationCountry":"Ukraine" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"T355", "InterventionBrowseLeafName":"Acidophilus", "InterventionBrowseLeafAsFound":"Acidophilus", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Ot", "InterventionBrowseBranchName":"Other Dietary Supplements" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007239", "ConditionMeshTerm":"Infection" },{ "ConditionMeshId":"D000003141", "ConditionMeshTerm":"Communicable Diseases" },{ "ConditionMeshId":"D000012141", "ConditionMeshTerm":"Respiratory Tract Infections" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13561", "ConditionBrowseLeafName":"Respiratory Tract Infections", "ConditionBrowseLeafAsFound":"Respiratory Tract Infections", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" } ] } } } } } }