Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-01-12 @ 10:54 AM
Study NCT ID:
NCT02456805
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternate Formula Feedings in Formula Intolerant Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1997-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool Characteristics', 'timeFrame': 'Change from Baseline (Study Day 1) to Study Day 15', 'description': 'Parent questionnaire'}], 'secondaryOutcomes': [{'measure': 'Formula Intake', 'timeFrame': 'Change from Baseline (Study Day 1) to Study Day 15', 'description': 'Parent questionnaire on volume consumed'}, {'measure': 'Incidence of spit up/vomiting', 'timeFrame': 'Change from Baseline (Study Day 1) to Study Day 15', 'description': 'Parent questionnaire'}, {'measure': 'Weight', 'timeFrame': 'Change from Baseline (Study Day 1) to Study Day 15', 'description': 'Measured weight at visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Tolerance']}, 'descriptionModule': {'briefSummary': 'This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Weeks', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.\n* Infants whose physicians had made a recommendation that the parents change the infant's feeding.\n* Full term infants at birth with a gestational age of 37 to 42 weeks.\n* Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.\n\nExclusion Criteria:\n\n* Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.\n* Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease."}, 'identificationModule': {'nctId': 'NCT02456805', 'briefTitle': 'Alternate Formula Feedings in Formula Intolerant Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Efficacy of Alternate Formula Feedings in Formula Intolerant Infants', 'orgStudyIdInfo': {'id': 'AH23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infant Formula 1', 'description': 'A standard commercial milk-based infant formula', 'interventionNames': ['Other: Infant Formula 1']}, {'type': 'EXPERIMENTAL', 'label': 'Infant Formula 2', 'description': 'A standard commercial soy-based infant formula.', 'interventionNames': ['Other: Infant Formula 2']}], 'interventions': [{'name': 'Infant Formula 1', 'type': 'OTHER', 'description': 'Feed ab libitum', 'armGroupLabels': ['Infant Formula 1']}, {'name': 'Infant Formula 2', 'type': 'OTHER', 'description': 'Feed ab libitum', 'armGroupLabels': ['Infant Formula 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Alaska', 'country': 'United States', 'facility': "Arkansas Children's Hospital"}, {'zip': '80011', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Pediatric Associates', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30087', 'city': 'Stone Mountain', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northlake Pediatric, Associates', 'geoPoint': {'lat': 33.80816, 'lon': -84.1702}}, {'zip': '52001', 'city': 'Dubuque', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Medical Associates Clinic', 'geoPoint': {'lat': 42.50056, 'lon': -90.66457}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Baystate Medical Center, Children's Hospital", 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '44709', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Studies, Inc', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond Pediatrics', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'L1H', 'city': 'Oshawa', 'country': 'Canada', 'facility': 'Optimum Clinical Research', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}], 'overallOfficials': [{'name': 'John Lasekan, MBA, Ph.D, CCRP', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}