Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02375360
Status:
UNKNOWN
Last Update Posted:
2015-03-02
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OIT Effect on FAQLQ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '1 - 2 years'}]}, 'conditionsModule': {'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': 'Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).', 'detailedDescription': 'The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults \\> 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM.\n\nThe questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, teenagers and their parents and adults with food allergy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected food allergy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02375360', 'briefTitle': 'OIT Effect on FAQLQ', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy', 'orgStudyIdInfo': {'id': '52/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children 8-12- control', 'description': 'Children aged 8-12 years with food allergy who are not undergoing oral immunoterapy'}, {'label': 'Parents 0-12 - control', 'description': 'Parents to children aged 0-12 years with food allergy who are not undergoing oral immunoterapy'}, {'label': 'Children 8-12 - OIT', 'description': 'Children aged 8-12 years with food allergy who are undergoing oral immunoterapy', 'interventionNames': ['Other: Oral immunotherapy']}, {'label': 'Teenagers 13-17 - OIT', 'description': 'Teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy', 'interventionNames': ['Other: Oral immunotherapy']}, {'label': 'Adults >18 - OIT', 'description': 'Adults\\> 18 years with food allergy who are undergoing oral immunoterapy', 'interventionNames': ['Other: Oral immunotherapy']}, {'label': 'Parents 0-12 - OIT', 'description': 'Parents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy', 'interventionNames': ['Other: Oral immunotherapy']}, {'label': 'Parents 13-17 - OIT', 'description': 'Parents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy', 'interventionNames': ['Other: Oral immunotherapy']}], 'interventions': [{'name': 'Oral immunotherapy', 'type': 'OTHER', 'armGroupLabels': ['Adults >18 - OIT', 'Children 8-12 - OIT', 'Parents 0-12 - OIT', 'Parents 13-17 - OIT', 'Teenagers 13-17 - OIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arnon Elizur', 'role': 'CONTACT', 'email': 'elizura@gmail.com', 'phone': '97289779820'}], 'facility': 'Asaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}