Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01177605
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2010-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'lastUpdateSubmitDate': '2011-08-31', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Problems']}, 'descriptionModule': {'briefSummary': "This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '9 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child 9 - 48 months of age\n* Child has consumed a cow follow-on milk during the 48 hours prior to enrollment\n* Child's weight for age is within the 10th -90th percentiles\n* Child's length for age is within 10th - 90th percentiles\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Children who are receiving predominantly breast-milk\n* Serious concurrent illness\n* Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization\n* Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant."}, 'identificationModule': {'nctId': 'NCT01177605', 'briefTitle': 'Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'orgStudyIdInfo': {'id': '3376-1 (8575)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vanilla flavored milk-based beverage containing no prebiotics', 'description': 'Vanilla flavored milk-based beverage containing no prebiotics', 'interventionNames': ['Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Vanilla flavored milk-based beverage containing prebiotics', 'description': 'Vanilla flavored milk-based beverage containing prebiotics', 'interventionNames': ['Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics']}], 'interventions': [{'name': 'Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics', 'type': 'OTHER', 'description': 'Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics', 'armGroupLabels': ['Vanilla flavored milk-based beverage containing no prebiotics', 'Vanilla flavored milk-based beverage containing prebiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41830-380', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Federal University of Bahia School of Medicine', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}}}}