Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-22 @ 9:22 AM
Study NCT ID:
NCT00655720
Status:
COMPLETED
Last Update Posted:
2008-04-15
First Post:
2008-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects on Growth of a Non-Routine Infant Formula
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-10', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2008-04-09', 'lastUpdatePostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth (weight)', 'timeFrame': '106 days'}], 'secondaryOutcomes': [{'measure': 'Tolerance', 'timeFrame': '106 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infant formula'], 'conditions': ['Growth']}, 'referencesModule': {'references': [{'pmid': '19264721', 'type': 'DERIVED', 'citation': "Scalabrin DM, Johnston WH, Hoffman DR, P'Pool VL, Harris CL, Mitmesser SH. Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2009 Sep;48(7):734-44. doi: 10.1177/0009922809332682. Epub 2009 Mar 4."}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Days', 'minimumAge': '12 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term infant\n* Solely formula fed\n* 14 days of age\n\nExclusion Criteria:\n\n* History of underlying disease\n* Evidence of formula intolerance\n* Current illness'}, 'identificationModule': {'nctId': 'NCT00655720', 'briefTitle': 'The Effects on Growth of a Non-Routine Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants', 'orgStudyIdInfo': {'id': '3369-5'}, 'secondaryIdInfos': [{'id': '3369-5'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Other: infant formula']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Other: infant formula']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Other: infant formula']}], 'interventions': [{'name': 'infant formula', 'type': 'OTHER', 'otherNames': ['no other names for any of the intervention arms'], 'description': '1. hydrolyzed infant formula without probiotics\n2. hydrolyzed infant formula with probiotics\n3. hydrolyzed infant formula with probiotics', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Deolinda Scalabrin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kim Merkel', 'oldOrganization': 'Mead Johnson'}}}}