Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT04596059
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2020-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Journey of Children With Cow's Milk Protein Allergy in Mexico.
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth', 'timeFrame': 'Can be 2 weeks up to 2 months', 'description': '* the proportion of subjects with weight gain compared to the previous visit (%)\n* the proportion of subjects with height gain compared to the previous visit (%)\n* the proportion of subjects with both weight and height gain compared to the previous visit (%)'}, {'measure': 'Dermatological symptoms (SCORAD score)', 'timeFrame': 'Can be 2 weeks up to 2 months', 'description': 'The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)'}], 'secondaryOutcomes': [{'measure': 'Type of symptoms', 'timeFrame': 'Can be 2 weeks up to 2 months', 'description': 'Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)'}, {'measure': 'Number of symptoms', 'timeFrame': 'Can be 2 weeks up to 2 months', 'description': 'Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)'}, {'measure': 'Severity of symptoms', 'timeFrame': 'Can be 2 weeks up to 2 months', 'description': 'Severity of symptoms on first and second visit (based on clinical diagnosis)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Cow's Milk Protein Allergy"]}, 'referencesModule': {'references': [{'pmid': '36793546', 'type': 'DERIVED', 'citation': "Estrada Reyes E, Zepeda Ortega B, Ten Haaf D, Kudla U, Muhardi L, Hofman DL, Hageman JHJ, Huerta Hernandez RE. Symptom's resolution and growth outcome of children with cow's milk protein allergy consuming two hydrolyzed formulas: A retrospective study in Mexico. Front Allergy. 2023 Jan 30;4:1073430. doi: 10.3389/falgy.2023.1073430. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mexican children (≤24 months) diagnosed with or suspected of CMPA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).\n* Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020.\n* Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.\n\nExclusion Criteria:\n\n* Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.\n* Premature children, or children with low birth-weight (weight at birth \\<2.5 kg).\n* Subjects diagnosed with a metabolic condition that impacts development and growth.\n* Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.'}, 'identificationModule': {'nctId': 'NCT04596059', 'acronym': 'Friso02', 'briefTitle': "The Journey of Children With Cow's Milk Protein Allergy in Mexico.", 'organization': {'class': 'INDUSTRY', 'fullName': 'FrieslandCampina'}, 'officialTitle': 'A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months', 'orgStudyIdInfo': {'id': 'CEI00320171130/07/052020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Frisolac Gold Intensive HA', 'type': 'OTHER', 'otherNames': ['Frisolac Gold PEP AC'], 'description': 'Regular medical care'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Clinica San Antonio', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Pachuca', 'country': 'Mexico', 'facility': 'Clínica de Alergia Pediátrica', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}, {'city': 'Pachuca', 'country': 'Mexico', 'facility': 'Consultorio de Pediatria', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}, {'city': 'Pachuca', 'country': 'Mexico', 'facility': 'Hospital del Niño DIF', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}], 'overallOfficials': [{'name': 'Rosa E Huerta Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica de Alergia Pediátrica, México'}, {'name': 'Benjamin Zepeda Ortega, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica San Antonio, Mexico'}, {'name': 'Marlene Ruiz Castillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FrieslandCampina', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sprim Advanced Life Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}