Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 2:05 PM
Study NCT ID:
NCT01081067
Status:
COMPLETED
Last Update Posted:
2011-01-05
First Post:
2010-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
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': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-03', 'studyFirstSubmitDate': '2010-03-03', 'studyFirstSubmitQcDate': '2010-03-03', 'lastUpdatePostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stool Output']}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of probiotics on stool output in children 1 - 18 months old.', 'detailedDescription': 'Evaluate the effect of probiotics on stool output in children 1 - 18 months old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CPPHO \\[Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira Pediatirc Center\\] C-HUPES \\[Complexo Hospitalar Professor Edgar Santos (Professor Edgar Santos Hospital Complex)\\]', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children 1 - 18 months of age\n* acute diarrhea\n* adequately hydrated\n* signed informed consent\n\nExclusion Criteria:\n\n* exclusively or predominantly breast-feeding\n* bloody diarrhea\n* intercurrent illnesses that may affect study parameters\n* use of systemic antibiotics during the 72 hours prior to enrollment\n* use of anti-diarrheal medications at the time of enrollment\n* use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01081067', 'briefTitle': 'Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children', 'orgStudyIdInfo': {'id': '3377-1 (6008)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Routine cow milk-based infant formula'}, {'label': 'Investigational', 'description': 'Cow milk-based infant formula containing probiotics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40110-170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Hugo Ribeiro, Jr., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Edgard Santos University Hospital - UFBA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Deolinda Scalabrin, M.D.', 'oldOrganization': 'Mead Johnson Nutrition'}}}}