Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-29 @ 4:20 AM
Study NCT ID:
NCT00990002
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of A Children's Beverage Containing Different Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Immunity']}, 'descriptionModule': {'briefSummary': "Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children 2-4 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children 2-4 years of age, weight and length for age within the 10th to 90th percentiles as plotted on the NCHS growth chart\n* Consuming cow's milk for at least one month\n\nExclusion Criteria:\n\n* Serious concurrent illness or acute infection\n* Using systemic antibiotics or steroids\n* Recent probiotic use\n* Feeding difficulties or intolerance to cow's milk\n* Conditions effecting normal growth and development\n* Immunodeficiencies"}, 'identificationModule': {'nctId': 'NCT00990002', 'briefTitle': "Investigation of A Children's Beverage Containing Different Probiotics", 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': "INVESTIGATION OF CHANGES IN LEUKOCYTE POPULATIONS AMONG CHILDREN RECEIVING A FOLLOW-ON COW'S MILK-BASED FORMULA CONTAINING DIFFERENT BIOACTIVE INGREDIENTS.", 'orgStudyIdInfo': {'id': '6002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': "A children's milk-based beverage"}, {'label': 'experimental probiotic 1', 'description': "children's milk-based beverage containing a bioactive ingredient"}, {'label': 'experimental probiotic 2', 'description': "children's milk-based beverage containing a different bioactive ingredient"}]}, 'contactsLocationsModule': {'locations': [{'zip': '68010', 'city': 'Boys Town', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Boys Town National Research Hospital', 'geoPoint': {'lat': 41.26111, 'lon': -96.13196}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Father Flanagan's Boys' Home", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Bryan Liu', 'oldOrganization': 'Mead Johnson Nutrition'}}}}