Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-26 @ 5:40 AM
Study NCT ID:
NCT01354366
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2011-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Tolerance of Hypoallergenic Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-13', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight measured at each study visit', 'timeFrame': '3.5 months'}], 'secondaryOutcomes': [{'measure': 'Recall of infant formula intake at each study visit', 'timeFrame': '3.5 months'}, {'measure': 'Body Length and Head Circumference measured at each study visit', 'timeFrame': '3.5 months'}, {'measure': 'Recall of stool characteristics and tolerance at each study visit', 'timeFrame': '3.5 months'}, {'measure': 'Medically-confirmed adverse events collected throughout the study period', 'timeFrame': '3.5 months'}, {'measure': 'Parental Product Assessment Questionnaire completed at Study Visit 2', 'timeFrame': 'once'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth of Term Infants']}, 'referencesModule': {'references': [{'pmid': '34289820', 'type': 'DERIVED', 'citation': 'Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Days', 'minimumAge': '12 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Heatly, term infants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton, 12-16 days of age at randomization\n* Term infant with birth weight of a minimum of 2500 grams\n* Solely formula fed\n* Signed Informed Consent and Protected Health Information\n\nExclusion Criteria:\n\n* History of underlying metabolic or chronic disease or immunocompromised\n* Feeding difficulties or formula intolerance'}, 'identificationModule': {'nctId': 'NCT01354366', 'briefTitle': 'Growth and Tolerance of Hypoallergenic Formulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants', 'orgStudyIdInfo': {'id': '3383-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Marketed hypoallergenic infant formula containing a probiotic', 'interventionNames': ['Other: Infant formula']}, {'label': 'Experimental 1', 'description': 'An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control', 'interventionNames': ['Other: Infant formula']}, {'label': 'Experimental 2', 'description': 'An investigational hypoallergenic infant formula with a different protein content, without a probiotic', 'interventionNames': ['Other: Infant formula']}], 'interventions': [{'name': 'Infant formula', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Experimental 1', 'Experimental 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Pediatric Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southeastern Pediatric Associates', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '35126', 'city': 'Pinson', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pediatrics East - Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.68899, 'lon': -86.68332}}, {'zip': '72019', 'city': 'Benton', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Pediatric Clinic', 'geoPoint': {'lat': 34.56454, 'lon': -92.58683}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "The Children's Clinic of Jonesboro", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Pediatric Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric Group, P.C.', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'country': 'United States', 'facility': 'Altamonte Pediatric Associates', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Medical Association", 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '30721', 'city': 'Dalton', 'state': 'Georgia', 'country': 'United States', 'facility': "North Georgia Clinical Research Center/White's Pediatrics", 'geoPoint': {'lat': 34.7698, 'lon': -84.97022}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'PTCU/Children and Youth Project', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Owensboro Pediatrics', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Woburn Pediatric Associates', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Gretchen Swanson Center for Nutrition', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Capital Pediatrics & Adolescent Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Innovis Health South University', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pediatric Associates of Mt. Carmel, Inc', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45014', 'city': 'Fairfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pediatric Associates of Fairfield, Inc', 'geoPoint': {'lat': 39.34589, 'lon': -84.5605}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Red Lion Pediatrics', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Primary Physicians Research, Inc', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Jackson Clinic - North Jackson', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Holston Medical Group', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Diagnostic Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Timothy Cooper, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Timothy Cooper, M.D.', 'oldOrganization': 'Mead Johnson Nutrition'}}}}