Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT02021058
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Unsettled Infants Experiencing Feeding Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2016-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline to 14 days in fuss-cry behavior', 'timeFrame': 'from baseline to 14 days', 'description': 'fuss-cry behavior per 24 hours'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to 14 days in GI symptoms', 'timeFrame': 'from baseline to 14 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Disorder']}, 'referencesModule': {'references': [{'pmid': '33029552', 'type': 'DERIVED', 'citation': 'Vivatvakin B, Estorninos E, Lien R, Lee HC, Hon KLE, Lebumfacil J, Cercamondi CI, Volger S. Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial. Glob Pediatr Health. 2020 Sep 25;7:2333794X20954332. doi: 10.1177/2333794X20954332. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance', 'detailedDescription': 'The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '30 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Full term infants, singleton, healthy at birth\n2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.\n3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.\n4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Infants who are consuming any amount of supplemental human milk\n2. Infants who are consuming weaning foods or beverages other than infant formula\n3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy\n4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance\n5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment"}, 'identificationModule': {'nctId': 'NCT02021058', 'briefTitle': 'Study in Unsettled Infants Experiencing Feeding Intolerance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance', 'orgStudyIdInfo': {'id': '13.10.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Formula', 'description': 'Experimental Formula', 'interventionNames': ['Other: Experimental Formula']}, {'type': 'OTHER', 'label': 'Standard Formula', 'description': 'Standard Control formula', 'interventionNames': ['Other: Standard control formula']}], 'interventions': [{'name': 'Experimental Formula', 'type': 'OTHER', 'description': 'Experimental formula', 'armGroupLabels': ['Experimental Formula']}, {'name': 'Standard control formula', 'type': 'OTHER', 'description': 'Standard Infant formula', 'armGroupLabels': ['Standard Formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong'}, {'zip': '1780', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'Asian Hospital and Medical Center', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'Hsiang, Taoyan Hsien', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Linkou'}, {'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital - Tamsui', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Mackay Memorial Hospital - Taipei', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10330', 'city': 'Pratumwan, Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Associate Professor Boosba Vivatvakin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Department, Faculty of Medicine, Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}