Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT03223792
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2017-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance Of A Partially-Hydrolyzed Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool consistency measured by MJN stool consistency scale', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': '14 days'}, {'measure': 'Formula acceptance measured by intake diary', 'timeFrame': '14 days'}, {'measure': 'Formula gastrointestinal tolerance measured by diary', 'timeFrame': '14 days'}, {'measure': 'Bowel movement characteristics by diary', 'timeFrame': '14 days'}, {'measure': 'Medically confirmed adverse events throughout the study period', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stool']}, 'descriptionModule': {'briefSummary': 'This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '300 Days', 'minimumAge': '28 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Singleton 28-300 days of age at randomization\n* Gestational age less than or equal to 35 weeks\n* Receiving minimum 18oz infant formula in the 24hrs prior to randomization\n* History of hard stools or stooling difficulty\n* Signed informed consent and protected health information\n\nExclusion Criteria:\n\n* Current diagnosis of cow's milk protein allergy or intolerance\n* Use of extensively hydrolyzed or amino acid formula at randomization\n* Any abdominal or gastrointestinal surgery prior to randomization\n* History of underlying metabolic or chronic disease or congenital malformation\n* Organic causes of constipation"}, 'identificationModule': {'nctId': 'NCT03223792', 'briefTitle': 'Acceptance Of A Partially-Hydrolyzed Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Acceptance Of A Partially-Hydrolyzed Infant Formula', 'orgStudyIdInfo': {'id': '3389-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational', 'interventionNames': ['Other: Investigational']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': "Routine cow's milk-based infant formula", 'armGroupLabels': ['Control']}, {'name': 'Investigational', 'type': 'OTHER', 'description': "Partially-hydrolyzed cow's milk protein infant formula", 'armGroupLabels': ['Investigational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Pediatric Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southeastern Pediatric Associates', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Pediatric Clinic', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Children's Clinic of Jonesboro, P.A.", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '47725', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinical Research', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatrics/Adult Research', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Owensboro Pediatrics', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatric Research', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75605', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'facility': 'DCOL Center for Clinical Research', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}], 'overallOfficials': [{'name': 'Steven Wu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}