Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT04957992
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, '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': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Formula Satisfaction Questionnaire', 'timeFrame': '28 Days of Age to 6 Months of Age', 'description': 'Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative'}, {'measure': 'Toddler Drink Satisfaction Questionnaire', 'timeFrame': '18 Months of Age to 24 Months of Age', 'description': 'Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative'}, {'measure': 'Infant Feeding and Stool Patterns Questionnaire', 'timeFrame': '28 Days of Age to 119 Days of Age]', 'description': 'Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never'}, {'measure': 'Infant and Toddler Behavior Questionnaire', 'timeFrame': '119 Days of Age', 'description': 'Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never'}, {'measure': 'Product Intake', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Parent completed intake diary'}, {'measure': 'Dietary Intake', 'timeFrame': '6 Months of Age to 24 Months of Age', 'description': 'Parent completed 24-hour recall'}, {'measure': 'Stool Sample', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Microbiota characterization; Subset of subjects'}, {'measure': 'Bayley™-4 Scale of Infant & Toddler Development IV', 'timeFrame': '12 Months of Age to 24 Months of Age', 'description': 'Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects'}, {'measure': 'MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences', 'timeFrame': '12 Months of Age to 24 Months of Age', 'description': 'Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups'}, {'measure': 'Modified Home Short Form', 'timeFrame': '6 Months of Age to 24 Months of Age]', 'description': 'Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups'}, {'measure': 'Medications', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Medication usage including frequency and reason for use'}, {'measure': 'Adverse Events', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Parent reported adverse events'}, {'measure': 'Health Resource Utilization', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Number of visits'}, {'measure': 'Missed Parental Work Days', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Parent reported number of days'}, {'measure': 'Blood Collection', 'timeFrame': '6 and 24 Months of Age', 'description': 'Blood Immune Markers; Subset of subjects'}], 'primaryOutcomes': [{'measure': 'Growth', 'timeFrame': 'Study Day 1 to 6 Months of Age', 'description': 'weight for age z-score'}], 'secondaryOutcomes': [{'measure': 'Incidence of respiratory infection between study groups', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Adverse event reports'}, {'measure': 'Number of respiratory infection episodes between study groups', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Adverse event reports'}, {'measure': 'Incidence of infection morbidity between study groups', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Adverse event reports'}, {'measure': 'Number of episodes of infection morbidity between study groups', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Adverse event reports'}, {'measure': 'Weight', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Interval weight gain per day'}, {'measure': 'Length', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Interval length gain per day'}, {'measure': 'Head Circumference', 'timeFrame': 'Study Day 1 to 24 Months of Age', 'description': 'Interval head circumference gain per day'}, {'measure': 'Gastrointestinal Tolerance', 'timeFrame': 'Study Day 1 to 12 months of Age', 'description': 'Parent completed diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is judged to be in good health as determined from participant's medical history\n* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report\n* Participant's 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 feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life\n* Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage\n* Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study\n* Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP\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* If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.\n* If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.\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* Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant\n* Suspected maternal substance abuse including alcohol\n* Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance\n* Participant is in another study that has not been approved as a concomitant study by AN\n* Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment\n* Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment"}, 'identificationModule': {'nctId': 'NCT04957992', 'briefTitle': 'BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age', 'orgStudyIdInfo': {'id': 'AL51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Feeding Group', 'description': 'Milk based product', 'interventionNames': ['Other: Control Infant Formula', 'Other: Control Toddler Drink']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Feeding Group', 'description': 'Milk based product with oligosaccharides', 'interventionNames': ['Other: Experimental Infant Formula', 'Other: Experimental Toddler Drink']}, {'type': 'OTHER', 'label': 'Human Milk Reference Group', 'description': 'Human Milk', 'interventionNames': ['Other: Human Milk', 'Other: Human Milk Supplemental Formula', 'Other: Human Milk Toddler Drink']}], 'interventions': [{'name': 'Control Infant Formula', 'type': 'OTHER', 'description': 'Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age', 'armGroupLabels': ['Control Feeding Group']}, {'name': 'Control Toddler Drink', 'type': 'OTHER', 'description': '\\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age', 'armGroupLabels': ['Control Feeding Group']}, {'name': 'Experimental Infant Formula', 'type': 'OTHER', 'description': 'Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age', 'armGroupLabels': ['Experimental Feeding Group']}, {'name': 'Experimental Toddler Drink', 'type': 'OTHER', 'description': '\\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age', 'armGroupLabels': ['Experimental Feeding Group']}, {'name': 'Human Milk', 'type': 'OTHER', 'description': 'Ad libitum or as instructed by HCP', 'armGroupLabels': ['Human Milk Reference Group']}, {'name': 'Human Milk Supplemental Formula', 'type': 'OTHER', 'description': 'Ad libitum if consuming supplemented formula; feeding period up to 12 months of age', 'armGroupLabels': ['Human Milk Reference Group']}, {'name': 'Human Milk Toddler Drink', 'type': 'OTHER', 'description': '\\~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age', 'armGroupLabels': ['Human Milk Reference Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'MedPharmics, LLC 3192', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '71943', 'city': 'Glenwood', 'state': 'Arkansas', 'country': 'United States', 'facility': 'HealthStar Research', 'geoPoint': {'lat': 34.32677, 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