Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-01 @ 10:24 AM
Study NCT ID:
NCT03680066
Status:
TERMINATED
Last Update Posted:
2023-12-05
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D021183', 'term': 'Peanut Hypersensitivity'}, {'id': 'D021184', 'term': 'Nut Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'recruitment stopped due to low number of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).', 'timeFrame': 'At study entry', 'description': 'Result of the food challenges with foods labelled with "may contain traces" (tolerated or reacted).'}], 'secondaryOutcomes': [{'measure': 'Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.', 'timeFrame': 'During 3 months follow-up', 'description': 'Tolerance to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (reactions / no reactions to these foods).'}, {'measure': 'Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.', 'timeFrame': 'During 3 months follow-up', 'description': 'Frequency of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (number of reactions).'}, {'measure': 'Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up.', 'timeFrame': 'During 3 months follow-up', 'description': 'Severity of reactions to foods labelled with "may contain traces" eaten normally during a 3 months follow-up (severity of reactions by reaction type).'}, {'measure': 'Changes of quality of life after 3 months without restriction of foods labelled with "may contain traces", compared to baseline when restricting.', 'timeFrame': 'At entry and after 3 months', 'description': 'Changes of quality of life measured with the age-appropriate "Food allergy quality of life questionnaire (0-12 years \\[parents\\], 7-12 years \\[patients\\], or 13-17 years \\[patients\\]. Results (on a continuous numerical ranking from 1 to 6 for each item) after 3 months without restriction of foods labelled with "may contain traces", are compared to baseline when restricting.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peanut allergy', 'Tree Nut allergy', 'Precautionary allergen labeling', 'May contain traces', 'Allergen threshold'], 'conditions': ['Food Allergy', 'Peanut Allergy', 'Tree Nut Allergy']}, 'descriptionModule': {'briefSummary': 'This protocol will help better define whether patients with peanut and/or tree nut food allergy can tolerate traces in products with precautionary allergen labelling.', 'detailedDescription': 'Visit 1 (V1): During this visit at the Pediatric Research Platform at the Children\'s Hospital, subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces" by following safety and accuracy guidelines for food challenges (7). The following foods (similar for all patients) will be given in one dose in the size of a regular serving:\n\n* cookies, max 30 g;\n* chocolate, max 30 g;\n* breakfast cereals, max 50 g.\n\nEach meal will be administered with a 1 hour observation period in between and at the end.\n\nIf the patient does not react to any of the foods or has only oral itching (mild symptoms), he/she will be instructed to stop the ban on "may contain" foods and eat them regularly. If the patient has more than mild symptoms, the study will be stopped and the patient will be banned from eating foods with traces. The study subjects with a negative challenge and instructed to eat foods with the "may contain" label will be provided emergency medications and instruction on when and how to use them according to current guidelines (8).\n\nAn age appropriate quality of life questionnaire will be filled out by the parents/patient during the visit.\n\nFor the following 3 months after "may contain food" challenges, the patients will be invited to eat on a regular basis any foods labeled as "may contain" tree nuts and/or peanuts and record the consumption on a diary. Such foods will only be eaten in presence of a family member instructed for the measures to be taken in case of a reaction. They will record any history of reaction and contact the study team. The brand name of the food, and if available the batch will be recorded. The participants will store the study food and its packaging safely in a box and bring it along at V2 for allergen content analysis.\n\nIf a reaction occurs, the food will be analyzed for allergen content by immunoaffinity capillary elecrophoresis-matrix assisted laser desorption/ionization mass spectrometry, as well as a simplified version of this technique, the immunomagnetic separation -matrix-assisted laser desorption/ionization mass spectrometry.\n\nVisit 2 (V2): During this visit, the parents/patients will report on the brand, the frequency and the amount of "may contain" foods eaten since V1.\n\nThe quality of life questionnaire will be filled out again by the parents/patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-18 years at time of inclusion\n* Tree nut or peanut allergy documented by:\n\n * Positive skin prick tests (SPTs) to peanut and/or tree nuts\n * Positive specific IgE (sIgE) to peanut and/or tree nuts ( ≥0.35 kU/L)\n * A recent (\\< 1 year) positive food challenge, reacting to the dose of 30 mg of proteins or below.\n* Parent/Legal guardian has been informed about the study and has signed Informed Consent Form\n\nExclusion Criteria:\n\n* History of a moderate or severe reaction during a food challenge with a dose of 30 mg of proteins or less.\n* Expected non-adherence to the study protocol.\n* Severe or uncontrolled asthma.'}, 'identificationModule': {'nctId': 'NCT03680066', 'briefTitle': 'Study to Assess Tolerance of Traces in Peanut/Tree Nut Allergic Children.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Assessing Tolerance to "May Contain Traces" Processed Foods in Tree Nuts or Peanut Allergic Children.', 'orgStudyIdInfo': {'id': 'CCER 2017-01413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foods with traces', 'description': 'Oral food challenge with foods with traces', 'interventionNames': ['Other: Oral food challenge to foods with traces']}], 'interventions': [{'name': 'Oral food challenge to foods with traces', 'type': 'OTHER', 'description': 'Subjects will undergo an open food challenge to 3 processed foods labeled with "may contain traces". The following foods (similar for all patients) will be given in one dose in the size of a regular serving:\n\n* cookies, max 30 g;\n* chocolate, max 30 g;\n* breakfast cereals, max 50 g.\n\nEach meal will be administered with a 1 hour observation period in between and at the end.', 'armGroupLabels': ['Foods with traces']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Pediatric Allergy Unit - University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Philippe Eigenmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Pediatric Allergy Unit, Department of Pediatrics', 'investigatorFullName': 'Philippe Eigenmann', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}