Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-12 @ 3:54 PM
Study NCT ID:
NCT02032056
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007154', 'term': 'Immune 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'}]}}, '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': 40}}, 'statusModule': {'whyStopped': 'Changes in study design', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in biological markers for the immune system', 'timeFrame': 'At baseline and after 6 mo', 'description': 'Analysis of biological material investigating the effect on the immune system by biological markers .'}, {'measure': 'Change from baseline in biological markers for gastro-intestinal tract', 'timeFrame': 'At baseline and after 6 mo', 'description': 'Analysis of biological material investigating the effect on the gastrointestinal tract.'}, {'measure': 'Change from baseline in Biological markers of allergy', 'timeFrame': 'At baseline and after 6 mo', 'description': 'analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo'}], 'primaryOutcomes': [{'measure': 'Number of days absent from day care due to respiratory and gastrointestinal infections', 'timeFrame': 'Up to 6 month', 'description': 'Recorded weekly by the parents using web-based questionnaires'}], 'secondaryOutcomes': [{'measure': 'Acute upper respiratory tract infections', 'timeFrame': 'Up to 6 month', 'description': 'Number of days with acute upper respiratory tract infections (URTI); Number of children with at least 1 episode of URTI; Number of children with at least 3 episodes of URTI; Number of URTI episodes/child/year; Duration of URTI episodes (days);\n\nAdditionally,symptoms of cold (defined as 2 days with runny/stuffy nose or cough)\n\nRecorded by the parents daily/weekly using web-based questionnaires.'}, {'measure': 'Acute lower respiratory infections', 'timeFrame': 'Up to 6 month', 'description': 'Number of children with at least 1 episode of a lower respiratory tract infection (LRTI).\n\nLRTI include bronchitis and pneumonia\n\nRecorded by the parents weekly using web-based questionnaires.'}, {'measure': 'Gastrointestinal infections', 'timeFrame': 'Up to 6 month', 'description': 'Number of children with at least 1 episode of diarrhea; Duration of episodes with diarrhea(days); Number of episodes/child/year with diarrhea; Number of days with vomiting.\n\nRecorded by the parents daily using web-based questionnaires'}, {'measure': 'Fever', 'timeFrame': 'Up to 6 month', 'description': 'Number of days with fever\n\nRecorded by the parents using web-based questionnaires'}, {'measure': 'Antibiotic use', 'timeFrame': 'Up to 6 month', 'description': 'Number of treatments with antibiotics during the intervention period\n\nRecorded weekly by the parents using web-based questionnires'}, {'measure': 'Allergies', 'timeFrame': 'Up to 6 month', 'description': 'Number of children developing allergies during the intervention period (asthma, allergic rhinitis, atopic dermatitis, food allergies); Age for diagnosis of allergies; Use of medication due to allergies.\n\nRecorded by the parents monthly using web-based questionnaires'}, {'measure': 'Absence from day care due to illness other than infections', 'timeFrame': 'Up to 6 month', 'description': 'Number of days the child is absent from day care due to illness, which is not due to infections.\n\nRecorded by the parents weekly using web-based questionnaires'}, {'measure': 'Parental absence from work due to illness of the child', 'timeFrame': 'Up to 6 month', 'description': 'Number of days a parent is absent from work due to illness of the child (infections and other illnesses, respectively)\n\nRecorded by the parents weekly using web-based questionnaires'}, {'measure': 'Medical visits', 'timeFrame': 'Up to 6 month', 'description': 'Number of visits to a doctor due to infections and other illnesses, respectively.\n\nRecorded by the parents using web-based questionnaires'}, {'measure': 'Change from baseline in Thymus size', 'timeFrame': 'At baseline and after 6 mo (end of intervention)', 'description': 'Change in thymic size during intervention period will be evaluated using ultraound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infections', 'Allergy', 'Immune function', 'Microbiota', 'infant'], 'conditions': ['Days Absent From Day Care', 'Respiratory Tract Infections', 'Gastrointestinal Infections', 'Allergy']}, 'descriptionModule': {'briefSummary': 'The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Months', 'minimumAge': '9 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9 - 12 1/2 month at intervention start\n* Start in daycare 4 +/- 2 weeks after intervention start\n* Single born\n\nExclusion Criteria:\n\n* Children born before 37th gestational week\n* Children with a birth weight \\< 2500 g\n* Children suffering from severe chronic illness\n* Children receiving regular medication\n* Children who have received antibiotics within a month before intervention start\n* Children whose parents do not speak Danish'}, 'identificationModule': {'nctId': 'NCT02032056', 'acronym': 'ProbiComp', 'briefTitle': 'Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period', 'orgStudyIdInfo': {'id': 'H-3-2013-064'}, 'secondaryIdInfos': [{'id': 'H-3-2013-064', 'type': 'OTHER_GRANT', 'domain': 'The Danish Council for Strategic Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotic (10^9 cfu/day)', 'description': 'Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10\\^9 cfu/day, provided as powder in a sachet which can be added to food or drink.', 'interventionNames': ['Dietary Supplement: Probiotic (10^9 CFU/day)']}, {'type': 'EXPERIMENTAL', 'label': 'probiotic (10^8 cfu/day)', 'description': 'Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10\\^8 cfu/day, provided as powder in a sachet which can be added to food or drink.', 'interventionNames': ['Dietary Supplement: Probiotic (10^8 CFU/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'provided as powder in a sachet which can be added to food or drink.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotic (10^9 CFU/day)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bifidobacterium animalis ssp. Lactis (BB12)'], 'armGroupLabels': ['probiotic (10^9 cfu/day)']}, {'name': 'Probiotic (10^8 CFU/day)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bifidobacterium animalis ssp. Lactis (BB12)'], 'armGroupLabels': ['probiotic (10^8 cfu/day)']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Council for Strategic Research', 'class': 'OTHER'}, {'name': 'Chr Hansen', 'class': 'INDUSTRY'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Statens Serum Institut', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}