Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-09 @ 11:27 AM
Study NCT ID:
NCT03679234
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2018-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Infant Formula on Caregiver-perceived Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant GI Symptom Burden', 'timeFrame': '3 weeks', 'description': 'Study personnel will administer questionnaire'}], 'secondaryOutcomes': [{'measure': 'Formula Intake', 'timeFrame': '24 hours', 'description': 'Caregivers will document on diary records'}, {'measure': 'Fussiness', 'timeFrame': '24 hours', 'description': 'Caregivers will document on diary records'}, {'measure': 'Formula Satisfaction Questionnaire', 'timeFrame': '3 weeks', 'description': 'Study personnel will administer questionnaire'}, {'measure': 'Adverse Events', 'timeFrame': '24 hours and 3 weeks', 'description': 'Assessed throughout study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Infants']}, 'descriptionModule': {'briefSummary': 'Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy infant\n* Full-term (\\> 37 weeks gestation)\n* Birth weight \\> 2500 and \\< 4500 g\n* 14-60 days of age on enrollment\n* Singleton birth\n* Infant's mother has elected not to breastfeed prior to enrollment\n* Infant exclusively formula-fed for at least 5 days prior to enrollment\n* Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days\n* Caregiver wishes to switch infant's formula\n* Has not received solid foods\n* Having obtained his/her legal representative's informed consent\n\nExclusion Criteria:\n\n* Known or suspected cow-milk allergy\n* Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)\n* Has switched formula more than two times since hospital discharge\n* Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)\n* Congenital illness or malformation that may affect infant feeding and/or growth\n* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment\n* Receiving probiotic supplements\n* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).\n* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition."}, 'identificationModule': {'nctId': 'NCT03679234', 'briefTitle': 'Impact of Infant Formula on Caregiver-perceived Intolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Impact of Infant Formula on Caregiver-perceived Intolerance', 'orgStudyIdInfo': {'id': '18.01.US.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Routine infant formula', 'interventionNames': ['Other: Routine infant formula']}], 'interventions': [{'name': 'Routine infant formula', 'type': 'OTHER', 'description': 'Routine infant formula with probiotic', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatrics Group', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Qualmedica Research', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatric Associates', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38116', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Midsouth Center for Clinical Research, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinPoint Trials', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Tanner Clinic', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}], 'overallOfficials': [{'name': 'Ryan Carvalho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestle Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}