Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT06589232
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Threshold Dose Distribution for Pistachio Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Threshold dose to pistachio', 'timeFrame': 'in the 4 hours of monitoring', 'description': 'in mg of protein'}], 'secondaryOutcomes': [{'measure': 'Threshold dose to cashew', 'timeFrame': 'in the 4 hours of monitoring', 'description': 'in mg of proteins'}, {'measure': 'Severity of the reaction during a positive pistachio oral provocation test', 'timeFrame': 'in the 4 hours of monitoring', 'description': 'defined by the COFAR (Consortium for Food Allergy Research) classification, from 1 to 5 and 1 is for mild symptoms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergy', 'Food Allergy']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. The secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and 3) evaluate predictive factors of a low reactogenic threshold', 'detailedDescription': 'Nuts, including almonds, walnuts, cashews, pistachio and hazelnut, are among the food allergens most frequently involved in food allergies in children with an estimated prevalence. between 0.05 and 4.9%.\n\nAccording to data from the Allergo-Vigilance Network, peanuts and the group of nuts, led by cashews, are alone responsible for 51.4% of food anaphylaxis in children.\n\nThe pistachio belongs to the same botanical family as the cashew nut (Anacardiumouest) and the mango (Mangifera indica): the anacardiaceae. Botanically, pistachio and cashew are closely related and can both be responsible for moderate to severe immediate allergic reactions. Furthermore, in a previous publication by the team, co-sensitization to pistachio was observed in 98% of children allergic to cashew nuts with only 34% confirmed allergic to pistachio.\n\nIn the case of allergy to both anacardiaceae, in a small number of patients, the investigators reported a reactogenic threshold for pistachio greater than or equal to that for cashew nuts.\n\nTo our knowledge, there is currently only one study that has evaluated the reactogenic threshold for pistachio, compared to other nuts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU.\n\nExclusion Criteria:\n\n* Patients who had a questionable oral pistachio provocation test.\n* Patients who had a negative pistachio oral provocation test.'}, 'identificationModule': {'nctId': 'NCT06589232', 'briefTitle': 'Threshold Dose Distribution for Pistachio Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Threshold Dose Distribution for Pistachio Allergy in Children', 'orgStudyIdInfo': {'id': '2024PI051'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Food allergy', 'description': 'Threshold dose to pistachio', 'interventionNames': ['Other: Food allergy']}], 'interventions': [{'name': 'Food allergy', 'type': 'OTHER', 'description': 'Threshold dose to pistachio', 'armGroupLabels': ['Food allergy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'France', 'country': 'France', 'facility': 'Centre Hospitalo-Universitaire de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Amandine DIVARET-CHAUVEAU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre hospitalo-universitaire de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Amandine DIVARET-CHAUVEAU', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}