[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541334":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cashew Immunotherapy","EXPERIMENTAL","Children with cashew allergy receiving OIT (OIT-oral immunotherapy).",[13],"Combination Product: Cashew immunotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Cashew avoidance","NO_INTERVENTION","Children with cashew allergy not receiving OIT (OIT-oral immunotherapy).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"COMBINATION_PRODUCT","Cashew immunotherapy","Following the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +\u002F- 3 weeks).",[9],[26],{"name":27,"affiliation":5,"role":28},"Agnieszka Szczukocka-Zych, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Katarzyna Grzela, PhD, MD","CONTACT","+48223179431","katarzyna.grzela@wum.edu.pl",{"name":27,"role":32,"phone":36,"phoneExt":18,"email":37},"+48223179427","agnieszka.szczukocka-zych@wum.edu.pl",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Warsaw","Masovian Voivodeship","02-091","Poland","PL",{"type":47,"coordinates":48},"Point",[49,50],21.01178,52.22977,{"lat":50,"lon":49},[53],{"name":27,"role":32,"phone":54,"phoneExt":18,"email":37},"+48 22 3179427",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100541334","efficacy-of-cashew-nut-protein-immunotherapy-100541334",false,"NCT06328504","Efficacy of Cashew Nut Protein Immunotherapy","Inclusion Criteria:\n\n* age between 4 and 17 years,\n* IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and\u002For specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA\u002Fl),\n* allergic reaction to cashew protein during oral food challenge (OFC),\n* Signed Informed Consent by parent\u002Flegal guardian and patient aged \\>16 years old,\n* Patient's and caregivers' cooperation with the researcher.\n\nExclusion Criteria:\n\n* no confirmed allergy to cashew,\n* negative provocation test with cashew,\n* severe asthma,\n* mild\u002Fmoderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) \\\u003C80% (less than 5 perc), FEV1\u002FFVC (forced expiratory volume at one second\u002Fforced vital capacity) \\\u003C75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,\n* oral\u002Fsublingual\u002Fsubcutaneous immunotherapy to other allergens during the study,\n* eosinophilic gastroenteritis,\n* chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,\n* taking medications:\n\n  * oral, daily steroid therapy \\>1 month in the past 12 months,\n  * a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,\n  * one-time oral steroid therapy (min. 7 days) in the last 3 months,\n  * biological treatment,\n  * need to take antihistamines continuously,\n  * therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,\n* pregnancy,\n* lack of consent to participate in the study,\n* lack of patient cooperation.","ALL","4 Years","17 Years",{"count":67,"type":68},39,"ESTIMATED","INTERVENTIONAL",[71],"NA","It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.",[74],"Food Allergy",[76,77,78,79],"cashew","food allergy","immunotherapy","children","2025-01-29",{"date":82,"type":83},"2025-01-30","ACTUAL",{"date":85,"type":83},"2024-03-28",{"date":87,"type":68},"2027-04-21",{"name":5,"class":6},1]