Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT02028156
Status:
TERMINATED
Last Update Posted:
2014-11-07
First Post:
2013-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding Intolerance in Formula-Fed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Fussiness', 'timeFrame': '0 to 15 days', 'description': 'Study phase 2; Parent completed questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Diarrhea', 'timeFrame': '0 to 4 weeks', 'description': 'Study phase 1; Parent completed questionnaire.'}, {'measure': 'Constipation', 'timeFrame': '0 to 4 weeks', 'description': 'Study phase 1; Parent completed questionnaire.'}, {'measure': 'Spit-up', 'timeFrame': '0 to 4 weeks', 'description': 'Study phase 1; Parent completed questionnaire.'}, {'measure': 'Gassiness', 'timeFrame': '0 to 4 weeks', 'description': 'Study phase 1; Parent completed questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria for Stage 1:\n\n* Singleton full term birth with birth weight of \\> 2500g.\n* Infant between 0 and 60 days of age.\n* Discontinuation of medications that might affect gastrointestinal (GI) tolerance.\n* Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.\n\nInclusion Criteria for Stage 2:\n\n* Infant was fed according to protocol in Stage 1 of the study.\n* Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.\n\nExclusion Criteria:\n\nExclusion Criteria for Stage 1:\n\n* Chromosomal or major congenital anomalies.\n* Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.\n* Hospitalization, other than for delivery, prior to enrollment.\n* Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.\n* More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.\n* Use of a prokinetic drug within 7 days before enrollment.\n\nExclusion Criteria for Stage 2:\n\n* Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).\n* Infant has immunization(s) within 3 days of enrollment in Stage 2."}, 'identificationModule': {'nctId': 'NCT02028156', 'briefTitle': 'Feeding Intolerance in Formula-Fed Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study', 'orgStudyIdInfo': {'id': 'DA06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partially Hydrolyzed Infant Formula', 'description': 'Fed ad lib.', 'interventionNames': ['Other: Partially Hydrolyzed Infant Formula']}], 'interventions': [{'name': 'Partially Hydrolyzed Infant Formula', 'type': 'OTHER', 'description': 'Commercially available infant formula', 'armGroupLabels': ['Partially Hydrolyzed Infant Formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Women and Children Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternity and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Xin Hua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shirley Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}