Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-17 @ 4:37 PM
Study NCT ID:
NCT03138057
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BM Characterization Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003963', 'term': 'Diaper Rash'}], 'ancestors': [{'id': 'D017453', 'term': 'Dermatitis, Irritant'}, {'id': 'D003877', 'term': 'Dermatitis, Contact'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-28', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine enzymes in infant stools', 'timeFrame': 'approximately 1 week', 'description': 'enzyme levels and activity of infant stools'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaper Rash']}, 'descriptionModule': {'briefSummary': "This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample of male and female infants who are not formula fed', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants aged 0-12 months\n\nExclusion Criteria:\n\n* Formula Fed\n* Use of topical or oral antibiotics or antifungals within the past 4 weeks'}, 'identificationModule': {'nctId': 'NCT03138057', 'briefTitle': 'BM Characterization Pilot', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kimberly-Clark Corporation'}, 'officialTitle': 'Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old', 'orgStudyIdInfo': {'id': '500-17-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Midwest Children's Health Research Institute", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Amy Bargen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Midwest Children's Health Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kimberly-Clark Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}