Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-01 @ 11:22 AM
Study NCT ID:
NCT04841850
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021184', 'term': 'Nut Hypersensitivity'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of patients in maintenance phase at the one-year consultation', 'timeFrame': 'at the one-year consultation', 'description': 'Patients are in maintenance phase at the end of the up-dosing phase and take regularly a quantity of hazelnut, usually superior to 800 mg, considered an acceptable protective dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hazelnut', 'Oral Immunotherapy', 'Children', 'Protocol', 'Efficiency', 'Tolerance'], 'conditions': ['Allergy, Nut', 'Pediatric ALL']}, 'referencesModule': {'references': [{'pmid': '35007745', 'type': 'DERIVED', 'citation': 'Sabouraud M, Bierme P, Andre-Gomez SA, Villard-Truc F, Payot F, Correard AK, Garnier L, Braun C. Real-life experience with hazelnut oral immunotherapy. Ann Allergy Asthma Immunol. 2022 Apr;128(4):432-438. doi: 10.1016/j.anai.2022.01.002. Epub 2022 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'Prevalence of food allergy in the world has been inscreasing in recent years. Among nut allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an alternatice to eviction. There are few published data concerning hazelnut OIT in Europe, where its consumption is nevertheless very high.\n\nThe main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.\n\nThe secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol.\n\nThe study is retrospective and observational, and is based on the collection of medical data from patient records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged under eighteen. With hazelnut allergy (convincing clinical history and positivity of hazelnut skin prick test history or specific IgE) Under IOT hazelnut protocol in Pneumology/allergology-paediatric department of the Mother and Child Hospital in Bron', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged Under eighteen years old\n* Hazelnut allergy (clinically and biologically)\n* Under IOT hazelnut protocol in Pneumo/allergology-paediatric departement of the Mother and Child hospital in Bron\n\nExclusion Criteria:\n\n* Lack of consent to be included in the study (by their parents)\n* Age \\> 18 years old'}, 'identificationModule': {'nctId': 'NCT04841850', 'acronym': 'ENOIME', 'briefTitle': 'Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinic And Biologic Efficiency And Tolerance Of Oral Immunotherapy Protocol In Hazelnut Allergic Children', 'orgStudyIdInfo': {'id': '186'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hazelnut allergic children under oral immunotherapy', 'description': '* Children Under eighteen years of age\n* Convincing clinical history of hazelnut allergy\n* Positive hazelnut prick test or specific IgE\n* Under IOT hazelnut protocol in pneumology and allergology-paediatric departement of the Mother and Child Hospital in Bron', 'interventionNames': ['Other: Clinical and biological characteristics']}], 'interventions': [{'name': 'Clinical and biological characteristics', 'type': 'OTHER', 'description': '* Age at beginning of IOT\n* Sex\n* Atopic and non atopic Comorbidities\n* Sensitization to aero-allergens\n* Sensitization to trophallergens\n* Stage of severity of the elicited reaction\n* Hazelnut Specific IgE + Cor a 1,8,9,14 before IOT and during follow up\n* Hazelnut skin prick test before IOT and during follow up\n* Adverse effects of IOT and their stage (in hospital and at home)\n* Use of adrenaline auto-injector (in hospital and at home)\n* Maintenance dose', 'armGroupLabels': ['Hazelnut allergic children under oral immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Pneumology allergology-paediatric department of the Mother and Child Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}