Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 3:11 PM
Study NCT ID:
NCT04059666
Status:
TERMINATED
Last Update Posted:
2022-08-25
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'Slow enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of stool microbiome between breast fed and formula fed babies', 'timeFrame': 'Over 60 days', 'description': 'Stool collection'}], 'secondaryOutcomes': [{'measure': 'Oral microbiome at each visit', 'timeFrame': 'Over 60 days', 'description': 'Buccal swab'}, {'measure': 'Stool molecules at each visit', 'timeFrame': 'Over 60 days', 'description': 'Stool sample'}, {'measure': '24 hour recall of formula intake', 'timeFrame': '2 times over 60 days', 'description': '24 hour recall questionnaire'}, {'measure': 'Stool color and consistency', 'timeFrame': '3 times over 60 days', 'description': 'Color and consistency'}, {'measure': 'Medically confirmed adverse events', 'timeFrame': '60 days', 'description': 'Medically confirmed adverse events'}, {'measure': 'Stool pH', 'timeFrame': 'Over 60 days', 'description': 'pH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Microbiome']}, 'referencesModule': {'references': [{'pmid': '39444571', 'type': 'DERIVED', 'citation': 'Christensen C, Kok CR, Harris CL, Moore N, Wampler JL, Zhuang W, Wu SS, Hutkins R, Izard J, Auchtung JM. Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial. Front Nutr. 2024 Oct 4;11:1465174. doi: 10.3389/fnut.2024.1465174. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Days', 'minimumAge': '7 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 7-18 days of age at Visit 1\n* Singleton birth\n* Gestational age of 37-42 weeks\n* Birth weight of 2500 g (5 lbs 8 oz) or more\n* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study\n* Signed informed consent and use of PHI for infant and birth mother\n* Receipt of three protocol-compliant Baseline stool samples\n\nInfants receiving formula:\n\n* Exclusively receiving infant formula for at least 24 hours prior to randomization\n* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period\n\nInfants receiving human milk:\n\n* Mother has intention to exclusively provide mother's-own breast milk for the duration of the study\n\nExclusion Criteria:\n\n* Caesarean delivery\n* Infant consumption of donor milk prior to randomization/registration\n* Maternal antibiotic use within 48 hours prior to or at time of delivery\n* Maternal antibiotic use while providing mother's-own breast milk to infant\n* Infant use of systemic antibiotics prior to randomization/registration\n* Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration\n* Weight at Visit 1 is \\<95% of birth weight\n* Infant use of probiotics\n* Evidence of significant feeding difficulties\n* Infant was born large for gestational age\n* History of underlying metabolic or chronic disease or congenital malformation\n* Infant is immunocompromised\n\nInfants receiving human milk:\n\n* Consumption of infant formula from 1 day of age"}, 'identificationModule': {'nctId': 'NCT04059666', 'briefTitle': "Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas", 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': "Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas", 'orgStudyIdInfo': {'id': '3390-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational', 'interventionNames': ['Other: Investigational']}, {'type': 'NO_INTERVENTION', 'label': "Mother's-own Breast Milk"}], 'interventions': [{'name': 'Investigational', 'type': 'OTHER', 'description': "Cow's milk-based Infant Formula with whey protein-lipid concentrate", 'armGroupLabels': ['Investigational']}, {'name': 'Control', 'type': 'OTHER', 'description': "Cow's milk-based Infant Formula", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Pediatric Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Research, LLC", 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Owensboro Pediatrics', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'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': 'Memphis & Shelby County Pediatric', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}