Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-25 @ 2:40 AM
Study NCT ID:
NCT05508750
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2022-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Safety Clinical Trial on a New Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-15', 'studyFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of AEs', 'timeFrame': '16 weeks', 'description': 'AEs reported during the study'}, {'measure': 'Caregiver report of tolerance obtained during 3-consecutive day intervals', 'timeFrame': '16 weeks', 'description': 'Caregiver report of fussiness, gassiness, and spitting up'}, {'measure': 'Caregiver report of stool characteristics obtained during 3-consecutive day intervals', 'timeFrame': '16 weeks', 'description': 'Caregiver report of stool consistency, color, and frequency'}, {'measure': 'Stool collection for microbiome testing', 'timeFrame': '16 weeks', 'description': 'Stool collection for microbiome testing at week 16 of feeding'}], 'primaryOutcomes': [{'measure': 'Weight gain from baseline to 16 weeks feeding', 'timeFrame': '16 weeks', 'description': 'Weight gain g/day'}], 'secondaryOutcomes': [{'measure': 'Length gain from baseline to 16 weeks feeding', 'timeFrame': '16 weeks', 'description': 'Length gain'}, {'measure': 'Head Circumference gain from baseline to 16 weeks feeding', 'timeFrame': '16 weeks', 'description': 'Head Circumference gain'}, {'measure': 'Volume of formula consumed during 3-consecutive day intervals', 'timeFrame': '16 weeks', 'description': 'Volume of formula consumed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant', 'formula', 'in-home'], 'conditions': ['Weight Gain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal term infant (37-42 weeks gestation at birth)\n* Infant \\<15 (+3) days of age at first study feeding, Birth constitutes day 0\n* Infant birth weight of ≥2500 g (5.5 lbs.)\n* Healthy Infant\n* Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)\n* Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)\n* Caregiver willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Infant born in multiple birth (i.e., twins, triplets, etc.)\n* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)\n* Infant with family history (parents or siblings) of confirmed Milk or Soy allergies\n* Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth\n* Caregiver intent to feed non-study formula or solid food during the study'}, 'identificationModule': {'nctId': 'NCT05508750', 'briefTitle': 'Growth and Safety Clinical Trial on a New Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jovie USA, LLC'}, 'officialTitle': 'A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula', 'orgStudyIdInfo': {'id': 'IQV-JOV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Infant Formula', 'description': 'New infant formula for healthy term infants', 'interventionNames': ['Other: New Infant Formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Infant Formula', 'description': 'Standard, commercially available infant formula for healthy term infants', 'interventionNames': ['Other: Commercial Infant Formula']}, {'type': 'NO_INTERVENTION', 'label': 'Human Milk', 'description': 'Breastfed infants serve as a reference group'}], 'interventions': [{'name': 'New Infant Formula', 'type': 'OTHER', 'description': 'New infant formula fed daily ad libitum', 'armGroupLabels': ['New Infant Formula']}, {'name': 'Commercial Infant Formula', 'type': 'OTHER', 'description': 'Commercially available infant formula fed daily ad libitum', 'armGroupLabels': ['Commercial Infant Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'ObvioHealth', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Parth Shah, MD FAPCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ObvioHealth'}, {'name': 'Dawn Ross, Director Clinical Project Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IQVIA RDS Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jovie USA, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IQVIA RDS Inc.', 'class': 'INDUSTRY'}, {'name': 'ObvioHealth', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}