Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02110732
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2014-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
Sponsor:
Organization:
Raw JSON
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GG.', 'unitOfMeasure': 'Samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Number of participants with tympanostomy'}, {'type': 'SECONDARY', 'title': 'Presence of Bacterial Pathogens in Middle Ear Effusion Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks\n\nLactobacillus rhamnosus GG'}, {'id': 'OG001', 'title': 'Crystalline Cellulose', 'description': 'Crystalline cellulose\n\nLactobacillus rhamnosus GG'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \\<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS."}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'After 3 weeks of oral consumption', 'description': 'Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.', 'unitOfMeasure': 'Samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Number of participants with tympanostomy'}, {'type': 'SECONDARY', 'title': 'Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks\n\nLactobacillus rhamnosus GG'}, {'id': 'OG001', 'title': 'Crystalline Cellulose', 'description': 'Crystalline cellulose\n\nLactobacillus rhamnosus GG'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'After 3 weeks of oral consumption', 'description': 'Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.', 'unitOfMeasure': 'Samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Number of participants with tympanostomy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks\n\nLactobacillus rhamnosus GG'}, {'id': 'FG001', 'title': 'Crystalline Cellulose', 'description': 'Crystalline cellulose\n\nLactobacillus rhamnosus GG'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks\n\nLactobacillus rhamnosus GG'}, {'id': 'BG001', 'title': 'Crystalline Cellulose', 'description': 'Crystalline cellulose\n\nLactobacillus rhamnosus GG'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2014-03-11', 'resultsFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-19', 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil', 'timeFrame': 'After 3 weeks of oral consumption', 'description': 'Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.'}], 'secondaryOutcomes': [{'measure': 'Presence of Bacterial Pathogens in Middle Ear Effusion Samples', 'timeFrame': 'After 3 weeks of oral consumption', 'description': 'Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.'}, {'measure': 'Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples', 'timeFrame': 'After 3 weeks of oral consumption', 'description': 'Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Upper Respiratory Infection', 'Acute Otitis Media']}, 'referencesModule': {'references': [{'pmid': '25085073', 'type': 'DERIVED', 'citation': 'Tapiovaara L, Lehtoranta L, Swanljung E, Makivuokko H, Laakso S, Roivainen M, Korpela R, Pitkaranta A. Lactobacillus rhamnosus GG in the middle ear after randomized, double-blind, placebo-controlled oral administration. Int J Pediatr Otorhinolaryngol. 2014 Oct;78(10):1637-41. doi: 10.1016/j.ijporl.2014.07.011. Epub 2014 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent otitis media\n* secretory otitis media\n* chronic rhinitis\n* recurrent sinusitis\n\nExclusion Criteria:\n\n* significant illness'}, 'identificationModule': {'nctId': 'NCT02110732', 'briefTitle': 'Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration', 'orgStudyIdInfo': {'id': 'HelsinkiUCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactobacillus rhamnosus GG', 'description': 'Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus rhamnosus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Crystalline cellulose', 'description': 'Crystalline cellulose', 'interventionNames': ['Dietary Supplement: Lactobacillus rhamnosus GG']}], 'interventions': [{'name': 'Lactobacillus rhamnosus GG', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Crystalline cellulose', 'Lactobacillus rhamnosus GG']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor/Chief Physician at Hospital District of Helsinki and Uusimaa', 'investigatorFullName': 'Anne pitkäranta', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}