Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-21 @ 11:11 PM
Study NCT ID:
NCT04529759
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2020-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Term Infants Fed Milk-Based 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant Stool Characteristics', 'timeFrame': 'Study Day 1 to 119 Days of Age', 'description': 'Parent Completed Diary'}, {'measure': 'Study Product Intake', 'timeFrame': 'Study Day 1 to 119 Days of Age', 'description': 'Parent Completed Diary'}, {'measure': 'Infant and Household Characteristics', 'timeFrame': 'Study Day 1 to 119 Days of Age', 'description': 'Parent reported lifestyle and illness questions'}, {'measure': 'Health Resource Utilization', 'timeFrame': 'Study Day 1 to 119 Days of Age', 'description': 'Number of Visits'}, {'measure': 'Infant Feeding and Stool Patterns Questionnaire', 'timeFrame': 'Exit or 119 Days of Age', 'description': 'Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction'}, {'measure': 'Infant Behavior Questionnaire', 'timeFrame': 'Exit or 119 Days of Age', 'description': 'Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction'}, {'measure': 'Formula Satisfaction Questionnaire', 'timeFrame': 'Exit or 119 Days of Age', 'description': 'Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction'}, {'measure': 'Adverse Events', 'timeFrame': 'Study Day 1 to 119 Days of Age', 'description': 'Standard adverse event reporting'}], 'primaryOutcomes': [{'measure': 'Mean rank stool consistency (MRSC)', 'timeFrame': 'Study Day 1 to 28 Days of Age', 'description': 'Parent Completed Diary'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '14 to 119 Days of Age', 'description': 'Interval weight gain per day'}, {'measure': 'Gastrointestinal tolerance', 'timeFrame': '14 to 119 Days of Age', 'description': 'Parent Completed Diary'}, {'measure': 'Length', 'timeFrame': '14 to 119 Days of Age', 'description': 'Interval length gain per day'}, {'measure': 'Head Circumference', 'timeFrame': '14 to 119 Days of Age', 'description': 'Interval head circumference gain per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tolerance']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Good health as determined from participant's medical history\n* Singleton from a full-term birth with a gestational age of 37-42 weeks\n* Birth weight was \\> 2490 g (\\~5 lbs. 8 oz.)\n* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study\n* Parent(s) confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study\n* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study\n\nExclusion Criteria:\n\n* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development\n* Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance\n* Participant is enrolled in another study that has not been approved as a concomitant study"}, 'identificationModule': {'nctId': 'NCT04529759', 'briefTitle': 'Healthy Term Infants Fed Milk-Based Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides', 'orgStudyIdInfo': {'id': 'AL39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Infant Formula', 'description': 'Feed ad libitum', 'interventionNames': ['Other: Control Infant Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Infant Formula', 'description': 'Feed ad libitum', 'interventionNames': ['Other: Experimental Infant Formula']}], 'interventions': [{'name': 'Control Infant Formula', 'type': 'OTHER', 'description': 'Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide', 'armGroupLabels': ['Control Infant Formula']}, {'name': 'Experimental Infant Formula', 'type': 'OTHER', 'description': 'Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend', 'armGroupLabels': ['Experimental Infant Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'PAS Research, LLC', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '43203', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Springs Medical Research', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute of Clinical Research', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Pediatric Research Center, LLC', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '38116', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Midsouth Center for Clinical Research', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'John Lasekan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}