Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-15 @ 3:35 AM
Study NCT ID:
NCT00653705
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-04', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Health care utilization and illness related costs as measured by number of physician visits, ER visits, hospitalizations, and antibiotics use. Also, child growth and quality of life. Exploratory biomarker outcomes in stool.', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Children', 'Child Care Center', 'Nutrition', 'Health promotion'], 'conditions': ["Children's Health and Growth", 'Childcare Absenteeism']}, 'referencesModule': {'references': [{'pmid': '25841539', 'type': 'DERIVED', 'citation': 'Ringel-Kulka T, Kotch JB, Jensen ET, Savage E, Weber DJ. Randomized, double-blind, placebo-controlled study of synbiotic yogurt effect on the health of children. J Pediatr. 2015 Jun;166(6):1475-81.e1-3. doi: 10.1016/j.jpeds.2015.02.038. Epub 2015 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to assess the effect of daily consumption of yogurt containing probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in out of home child care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An informed consent has been signed by the parents.\n* The child is at least one year old and has not had his 4th birthday at the beginning of the study\n* The child is healthy.\n* The child attends child care center at least 5 days a week, \\> 4 hours per day.\n\nExclusion Criteria:\n\n* Was born preterm.\n* Had a birth weight \\<2,500 g.\n* Has congenital anomalies.\n* Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery.\n* Has chronic disease or malignancy.\n* Has a serious, unstable medical condition.\n* Is Failure to Thrive (FTT) (\\<5th percentile of ideal body weight).\n* Has an allergy or atopic disease.\n* Has an allergy or intolerance to milk/dairy products.\n* Has an established diagnosis of lactase deficiency.\n* Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment).\n* Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)'}, 'identificationModule': {'nctId': 'NCT00653705', 'briefTitle': "The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism", 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': "The Effect of Daily Consumption of Yogurt Containing Bifidobacterium Lactis (BB12) on Children's' Health and Child Care Absenteeism", 'orgStudyIdInfo': {'id': '06-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'Children given probiotic BB12 enriched yogurt drink.', 'interventionNames': ['Other: Yogurt drink with probiotic bacteria BB12']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Children given dairy drink.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Yogurt drink with probiotic bacteria BB12', 'type': 'OTHER', 'description': 'Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Vanilla flavored dairy drink. One bottle a day for 16 weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill, School of Public Health', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Tamar Ringel-Kulka, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Mills', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Maternal and Child Health', 'investigatorFullName': 'Tamar Ringel-Kulka, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}