Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-18 @ 1:20 AM
Study NCT ID:
NCT03698058
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A2 GUM Post-Market Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall digestive comfort', 'timeFrame': 'Baseline to Study Day 14', 'description': 'Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).'}], 'secondaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Stool frequency reported by parents in 3-Day GI Symptoms Diary'}, {'measure': 'Stool consistency', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Stool consistency score reported by parents in 3-Day GI Symptoms Diary'}, {'measure': 'Consumption of other milk products', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Reported by parents on 3 consecutive days on Milk Intake Diary'}, {'measure': 'Child weight', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Weight as measured by study staff in health clinic'}, {'measure': 'Child height', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Weight as measured by study staff in health clinic'}, {'measure': 'Child head circumference', 'timeFrame': 'Baseline, Study Day 7, Study Day 14', 'description': 'Head circumference as measured by study staff in health clinic'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to Study Day 14', 'description': 'All adverse events reported by parents and confirmed by study investigator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Toddlers', 'A2', 'B-casein', 'Gut comfort', 'Growing up milk'], 'conditions': ['Protein Intolerance']}, 'descriptionModule': {'briefSummary': "This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.", 'detailedDescription': "This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.\n* Children 12 - 36 months of age at enrolment.\n* Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.\n* Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).\n* Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.\n\nExclusion Criteria:\n\n* Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.\n* Known and diagnosed cow's milk protein allergy.\n* Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.\n* Children who have known cognitive and developmental disorders."}, 'identificationModule': {'nctId': 'NCT03698058', 'briefTitle': 'A2 GUM Post-Market Effectiveness Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China', 'orgStudyIdInfo': {'id': '18.14.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A2 Growing Up Milk', 'interventionNames': ['Dietary Supplement: Toddler milk']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional non-A2 milk'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Other Growing Up Milk', 'interventionNames': ['Dietary Supplement: Toddler milk']}], 'interventions': [{'name': 'Toddler milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available toddler milk', 'armGroupLabels': ['A2 Growing Up Milk', 'Other Growing Up Milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Institute of Reproductive and Child Health, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}