Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT00760851
Status:
COMPLETED
Last Update Posted:
2011-03-18
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yogurt Study in Children 2-4 Years Old Attending Daycare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-17', 'studyFirstSubmitDate': '2008-09-24', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school', 'timeFrame': '90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probiotics', 'Child, preschool', 'Child Day Care Centers', 'Health', 'Immune system'], 'conditions': ['Infections, Respiratory', 'Diarrhea']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare.\n\nIn this study, participants will be asked to:\n\n1. Give their child 4 oz. of the test yogurt each day for 90 days\n2. Keep a daily diary of their child's health\n3. Collect 3 stool samples from their child at the start, middle, and end of the study\n4. Speak with research personnel on a bi-weekly basis regarding their child's health\n5. Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 2 to 4 years of age\n* Child attends daycare at least 3 days per week\n\nExclusion Criteria:\n\n* Caregiver does not speak English or Spanish\n* Caregiver does not agree to have their child refrain from cultured dairy products (yogurt) for the 105-day duration of the study\n* Caregiver does not agree to collect a stool sample from their child on Day 0, 45, and 105 of the study\n* Caregiver does not have a refrigerator to store the yogurt product at home\n* Child is currently receiving breast milk\n* Child has an allergy or hypersensitivity to milk proteins or other dairy food components such as lactose\n* Child has an allergy or hypersensitivity to strawberry or red food coloring\n* Child has a chronic disease\n* Child has had an infection or been sick 7 days prior to starting study\n* Child has had diarrhea or constipation 7 days prior to starting study\n* Child has a special diet as prescribed by a medical professional\n* Child has received antibiotics, antiseptics, antifungal, corticosteroids, anti-histamines, non steroidal anti-inflammatory drugs within 7 days prior to starting the study\n* Child has a congenital anomaly or birth defect that requires medical care'}, 'identificationModule': {'nctId': 'NCT00760851', 'acronym': 'SIPPY II', 'briefTitle': 'Yogurt Study in Children 2-4 Years Old Attending Daycare', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Study to Investigate the Potential of Probiotics II', 'orgStudyIdInfo': {'id': '2008-01852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bb-12 supplemented strawberry yogurt drink', 'interventionNames': ['Other: probiotic strain Bb-12']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Regular strawberry yogurt drink with no Bb-12 added', 'interventionNames': ['Other: no Bb-12']}], 'interventions': [{'name': 'probiotic strain Bb-12', 'type': 'OTHER', 'otherNames': ['Bifidobacterium lactis 12'], 'description': '10\\^9 CFU Bb-12 per 4 oz yogurt', 'armGroupLabels': ['1']}, {'name': 'no Bb-12', 'type': 'OTHER', 'description': 'yogurt identical to intervention yogurt, only without Bb-12 added.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Department of Family Medicine, Research Division', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Daniel Merenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Agriculture (USDA)', 'class': 'FED'}, {'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Daniel Merenstein, M.D.', 'oldOrganization': 'Georgetown University'}}}}