Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 11:01 AM
Study NCT ID:
NCT03967132
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2019-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Tolerance of 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': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stool Sample', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'Microbiota characterization'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Day of life 14 - 119', 'description': 'Weight gain per day'}], 'secondaryOutcomes': [{'measure': 'Stool Characteristics', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'Parent completed diary'}, {'measure': 'Formula Tolerance', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'Parent completed diary'}, {'measure': 'Length', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'Length gain per day'}, {'measure': 'Head Circumference (HC)', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'HC gain per day'}, {'measure': 'Illness Incidence', 'timeFrame': 'Study Day 1 to Day of life 119', 'description': 'Parent reported incidence of illness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro-Intestinal Tolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.'}, '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* If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.\n* If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.\n* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.\n* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 GI tolerance.\n* Participant participates in another study that has not been approved as a concomitant study by AN."}, 'identificationModule': {'nctId': 'NCT03967132', 'briefTitle': 'Growth and Tolerance of Infants Fed Milk-Based Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides', 'orgStudyIdInfo': {'id': 'AL29A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Infant Formula', 'description': 'Milk-based infant formula', 'interventionNames': ['Other: Control Infant Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Infant Formula', 'description': 'Milk-based Infant Formula with oligosaccharides', 'interventionNames': ['Other: Experimental Infant Formula']}, {'type': 'OTHER', 'label': 'Reference Group', 'description': 'Human-milk fed', 'interventionNames': ['Other: Reference Group']}], 'interventions': [{'name': 'Control Infant Formula', 'type': 'OTHER', 'description': 'Ready to feed infant formula, feed ad libitum', 'armGroupLabels': ['Control Infant Formula']}, {'name': 'Experimental Infant Formula', 'type': 'OTHER', 'description': 'Ready to feed infant formula, feed ad libitum', 'armGroupLabels': ['Experimental Infant Formula']}, {'name': 'Reference Group', 'type': 'OTHER', 'description': 'Human milk, breast feeding ad libitum', 'armGroupLabels': ['Reference Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Watching Over Mothers & Babies', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pediatric Medical Associates', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric Group, P.C.', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Phoenix Medical Research LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32829', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research-Deland, LLC a/b/a Accel Clinical Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Clinical Research Prime', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '47725', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic, Inc.', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Michael W. Simon, M.D., PSC', 'geoPoint': {'lat': 37.88063, 'lon': -84.573}}, {'zip': '42303', '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, LLC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Pediatric Research Center, LLC', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Holston Medical Group', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '38116', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Midsouth Center for Clinical Research', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78726', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'ARC Clinical Research at Wilson Parke', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ventavia Research Group, LLC', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ventavia Research Group', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76248', 'city': 'Keller', 'state': 'Texas', 'country': 'United States', 'facility': 'Ventavia Research Group, LLC 3078', 'geoPoint': {'lat': 32.93457, 'lon': -97.25168}}, {'zip': '77584', 'city': 'Pearland', 'state': 'Texas', 'country': 'United States', 'facility': 'Kagan Pediatrics - HD Research Corporation', 'geoPoint': {'lat': 29.56357, 'lon': -95.28605}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Plano Pediatrics - ACRC Trials', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Timberly Williams, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}