Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-28 @ 4:12 AM
Study NCT ID:
NCT01651195
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2012-07-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Probiotics and Infections in Conscripts in Military Service
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne.pitkaranta@hus.fi', 'phone': '+358406430511', 'title': 'Prof. Anne Pitkäranta', 'organization': 'Helsinki University Central Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 0, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 0, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 0, 'seriousNumAtRisk': 204, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo', 'otherNumAtRisk': 211, 'deathsNumAtRisk': 211, 'otherNumAffected': 0, 'seriousNumAtRisk': 211, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Sick Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'Days', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks'}, {'id': 'OG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks'}, {'id': 'OG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks'}, {'id': 'OG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks'}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.', 'otherAnalysisDescription': 'Result variables were analyzed according to "intention to treat" (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis.'}], 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'The number of sick days with respiratory and gastrointestinal symptoms and symptom incidence. Other outcome measures were the number and duration of infection episodes, the number of antibiotic treatments received, and the number of days out of service due to an infection. Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers. If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'According to the study nurse, the file containing number of sick days data of this particular study is no more available.'}, {'type': 'SECONDARY', 'title': 'Number and Duration of Infection Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}, {'units': 'Episodes', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'OG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Episodes', 'denomUnitsSelected': 'Episodes'}, {'type': 'SECONDARY', 'title': 'Number of Antibiotic Treatments Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}, {'units': 'Treatments', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'OG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Number of antibiotic treatments received were collected during the medical visits.', 'unitOfMeasure': 'Treatments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Treatments', 'denomUnitsSelected': 'Treatments'}, {'type': 'SECONDARY', 'title': 'Number of Days Out of Service Due to an Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}, {'units': 'Days', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'OG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'OG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced. Gastrointestinal tract infection episodes and symptom days were calculated in the same fashion except 14 non symptomatic days should be in between the two to be considered as two different episodes.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'FG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'FG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'FG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '204'}, {'groupId': 'FG003', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '211'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '108'}]}]}], 'preAssignmentDetails': 'Sample size was calculated on the assumption that the use of probiotic would result in a 17% reduction in the number of sick days estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.15000 and α=0.05), we needed 300 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Probiotic Tablet (Military Recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'BG001', 'title': 'Placebo Tablet (Military Recruits)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'BG002', 'title': 'Probiotic Tablet (Reserve Officer Candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks\n\nProbiotic'}, {'id': 'BG003', 'title': 'Placebo Tablet (Reserve Officer Candidates)', 'description': 'Chrystalline celluloce 2 x 2, 3 weeks\n\nPlacebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], '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': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 983}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2012-07-24', 'resultsFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-18', 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Sick Days', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'The number of sick days with respiratory and gastrointestinal symptoms and symptom incidence. Other outcome measures were the number and duration of infection episodes, the number of antibiotic treatments received, and the number of days out of service due to an infection. Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers. If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced.'}], 'secondaryOutcomes': [{'measure': 'Number and Duration of Infection Episodes', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers.'}, {'measure': 'Number of Antibiotic Treatments Received', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'Number of antibiotic treatments received were collected during the medical visits.'}, {'measure': 'Number of Days Out of Service Due to an Infection', 'timeFrame': 'Through study completion, an average of 4 months', 'description': 'If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced. Gastrointestinal tract infection episodes and symptom days were calculated in the same fashion except 14 non symptomatic days should be in between the two to be considered as two different episodes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Tract Infections', 'Gastrointestinal Diseases', 'Asthma Exacerbations']}, 'referencesModule': {'references': [{'pmid': '27048835', 'type': 'DERIVED', 'citation': 'Kalima K, Lehtoranta L, He L, Pitkaniemi J, Lundell R, Julkunen I, Roivainen M, Narkio M, Makela MJ, Siitonen S, Korpela R, Pitkaranta A. Probiotics and respiratory and gastrointestinal tract infections in Finnish military conscripts - a randomised placebo-controlled double-blinded study. Benef Microbes. 2016 Sep;7(4):463-71. doi: 10.3920/BM2015.0172. Epub 2016 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim was to study whether probiotic intervention has an impact on seasonal occurrence of upper respiratory and gastrointestinal infections in two different conscript groups. In a randomised, double-blinded, placebo controlled study a total of 983 healthy adults were enrolled from two intakes of conscripts. Conscripts were randomised to receive either a probiotic combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 (BB12) or a control chewing tablet twice daily for 150 days (recruits) or for 90 days (reserve officer candidates). Clinical examinations were carried out and daily symptom diaries were collected. Outcome measures were the number of days with respiratory and gastrointestinal symptoms and symptom incidence, number and duration of infection episodes, number of antibiotic treatments received and number of days out of service because of the infection. Statistically no significant differences were found between the intervention groups either in the risk of symptom incidence or duration. However, probiotic intervention was associated with reduction of specific respiratory infection symptoms in military recruits, but not in reserve officer candidates. Probiotics did not significantly reduce overall respiratory and gastrointestinal infection morbidity.', 'detailedDescription': 'Military conscripts are susceptible to respiratory and gastrointestinal tract infections. In previous studies probiotics have shown potency to reduce upper respiratory and gastrointestinal infections. The aim was to study whether probiotic intervention has an impact on seasonal occurrence of upper respiratory and gastrointestinal infections in two different conscript groups. In a randomised, double-blinded, placebo controlled study a total of 983 healthy adults were enrolled from two intakes of conscripts. Conscripts were randomised to receive either a probiotic combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 (BB12) or a control chewing tablet twice daily for 150 days (recruits) or for 90 days (reserve officer candidates). Clinical examinations were carried out and daily symptom diaries were collected. Outcome measures were the number of days with respiratory and gastrointestinal symptoms and symptom incidence, number and duration of infection episodes, number of antibiotic treatments received and number of days out of service because of the infection. Statistically no significant differences were found between the intervention groups either in the risk of symptom incidence or duration. However, probiotic intervention was associated with reduction of specific respiratory infection symptoms in military recruits, but not in reserve officer candidates. Probiotics did not significantly reduce overall respiratory and gastrointestinal infection morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults attending military service in July 2012 and healthy adults attending reserve office school in October 2012\n\nExclusion Criteria:\n\n* Regular use of oral corticosteroids\n* Regular consumption (over 3 times a week) of probiotic bacteria containing products 3 weeks before intervention'}, 'identificationModule': {'nctId': 'NCT01651195', 'briefTitle': 'Probiotics and Infections in Conscripts in Military Service', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Probiotic and Respiratory and Gastrointestinal Tract Infections in Finnish Military Conscripts - a Randomized and Placebo-controlled Double-blinded Study', 'orgStudyIdInfo': {'id': '189/13/03/00/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic tablet (military recruits)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks', 'interventionNames': ['Dietary Supplement: Probiotic', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablet (military recruits)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks', 'interventionNames': ['Dietary Supplement: Probiotic', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic tablet (reserve officer candidates)', 'description': 'Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks', 'interventionNames': ['Dietary Supplement: Probiotic', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablet (reserve officer candidates)', 'description': 'Crystalline cellulose 2 x 2, 3 weeks', 'interventionNames': ['Dietary Supplement: Probiotic', 'Other: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo tablet (military recruits)', 'Placebo tablet (reserve officer candidates)', 'Probiotic tablet (military recruits)', 'Probiotic tablet (reserve officer candidates)']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo tablet (military recruits)', 'Placebo tablet (reserve officer candidates)', 'Probiotic tablet (military recruits)', 'Probiotic tablet (reserve officer candidates)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamina', 'country': 'Finland', 'facility': 'The Finnish Defence Forces', 'geoPoint': {'lat': 60.56974, 'lon': 27.19794}}, {'city': 'Upinniemi', 'country': 'Finland', 'facility': 'The Finnish Defence Forces', 'geoPoint': {'lat': 60.03202, 'lon': 24.36424}}], 'overallOfficials': [{'name': 'Anne I Pitkäranta, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'Finnish Defense Forces', 'class': 'OTHER_GOV'}, {'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'}}}}