Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT01809951
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isomil Post Marketing Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein", 'timeFrame': '4-week'}], 'secondaryOutcomes': [{'measure': 'percentage of infants with gastrointestinal adverse events', 'timeFrame': '4-week'}, {'measure': 'percentage of infants with adverse events', 'timeFrame': '4-week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Cow's Milk Allergy"]}, 'descriptionModule': {'briefSummary': "The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Infants with symptoms suggestive adverse reactions to cow's milk protein", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* infants of 6 - 12 months of age\n* full term infants\n* birth weight more than 2500 grams\n* infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements\n* subject is prescribed a soy-based infant formula by physician\n\nExclusion Criteria:\n\n* established/suspected hypersensitivity fo soy\n* presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease\n* history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases\n* presence of severe gastrointestinal disorder\n* subject is participating in any interventional clinical study"}, 'identificationModule': {'nctId': 'NCT01809951', 'briefTitle': 'Isomil Post Marketing Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': "A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy", 'orgStudyIdInfo': {'id': 'ANID-1101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isomil Advance with LCP', 'description': '4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Divisi Alergi Imunologi FKUI RSCM', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Zakiudin Munasir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas Indonesia'}, {'name': 'Sumadiono, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'RS Sardjito, Jl Kesehatan No 1 Yogyakarta'}, {'name': 'Anang Endaryanto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric Society'}, {'name': 'Dina Muktiarti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sub Divisi Alergi Imunologi IKA FKUI, Jakarta'}, {'name': 'Dewi Kumara Wati, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'RSUP Sanglah, Jl Kesehatan No 1-10 Denpasar Bali'}, {'name': 'Budi Setiabudiawan, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'RS Hasan Sadikin Jl Pasteur No 38 Bandung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melva Louisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Melva Louisa', 'investigatorAffiliation': 'Indonesia University'}}}}