[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cashew-nut-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cashew-nut-allergy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100606053","phase-2-unc-cashew-sublingual-immunotherapy-100606053",false,"NCT07170540","UNC Cashew Sublingual Immunotherapy","Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)","CASCADES","Inclusion Criteria:\n\n* Age 1-11 years at enrollment\n* Cashew allergy, with allergy defined as:\n* History of clinical reaction to cashew AND cashew-specific IgE \\>\u002F=0.35 kUA\u002FL AND cashew SPT \\>\u002F=3 mm\n* OR if no prior reaction, cashew-specific IgE \\>\u002F=5 kUA\u002FL AND cashew SPT \\>\u002F=3 mm\n* Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment\n* If female of child-bearing potential, must have a negative urine or serum pregnancy test\n* If female of childbearing potential (defined as females who have reached menarche or who are 12 years or older), must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant and\u002For parent\u002Flegal guardian to give written informed consent and\u002For assent or comply with the study protocol\n* History of severe anaphylaxis to cashew defined as neurological compromise or requiring intubation\u002Fmechanical ventilation\n* Known oat, wheat, or glycerin allergy\n* Poorly controlled or severe asthma\u002Fwheezing at screening, defined by at least one of the following criteria:\n* Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma\n* History of 2 or more systemic corticosteroid courses within 6 months of screening or one course of systemic corticosteroids within 3 months of screening to treat asthma\u002Fwheezing\n* Prior intubation\u002Fmechanical ventilation for asthma\u002Fwheezing\n* Hospitalization or overnight Emergency Department (ED) visit for asthma\u002Fwheezing within 6 months of screening\n* Forced expiratory volume in one second (FEV1) \\\u003C80% of predicted or FEV1\u002Fforced vital capacity (FVC) \\\u003C75%, with or without controller medications (for participants \\>\u002F= 6 years and older, able to perform spirometry)\n* Peak expiratory flow rate (PEFR) \\\u003C80% of predicted for participants \\>6 and able to perform peak flow\n* Inhaled corticosteroid (ICS) dosing of \\>500 mcg daily fluticasone (or equivalent ICS)\n* Eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease\n* Inability to discontinue antihistamines at least 5 half-lives before scheduled SPT and DBPCFC\n* Food immunotherapy such as Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous (EPIT) for cashew or pistachio within 6 months of enrollment\n* Monoclonal antibodies such as omalizumab (Xolair), dupilumab (Dupixent), benralizumab (Fasenra), mepolizumab (Nucala), or other immunomodulatory therapy within 6 months of enrollment\n* Currently on dose escalation of environmental allergen immunotherapy (SCIT or SLIT). Individuals on maintenance allergen immunotherapy can be enrolled\n* Participation in any interventional study within the past 3 months\n* Pregnant or breastfeeding\n* Past or current medical condition or clinical significant laboratory abnormality that, in the opinion of the PI, would make the participant unsafe or otherwise unsuitable for participation in the clinical trial","ALL","1 Year","11 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.",[28,29],"Cashew Nut Allergy","Tree Nut Allergies",[31,32,33,34,35],"cashew allergy","tree nut allergy","food allergy","sublingual immunotherapy","SLIT","NOT_YET_RECRUITING","2026-04-13",{"date":39,"type":40},"2026-04-14","ACTUAL",{"date":42,"type":22},"2026-06",{"date":44,"type":22},"2028-12",{"name":46,"class":47},"University of North Carolina, Chapel Hill","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100587635","the-nacho-trial-nut-allergy-children-oit-100587635","NCT06930950","The NACHO Trial (Nut Allergy Children OIT)","Efficacy of Oral Immunotherapy for Cashew Allergy in Children Aged 1 to 17 Years: a Clinical Prospective Randomized Controlled Interventional Trial","Inclusion Criteria:\n\n1. Age 6 months - 17 years\n2. Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)\n3. Positive oral food challenge for cashew nut\n\nExclusion Criteria:\n\n1. Poor adherence\n2. Uncontrolled or severe asthma\n3. Uncontrolled active or severe or atopic dermatitis\n4. Chronic urticaria\n5. Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders\n6. Active malignant neoplasia\n7. Active systemic, autoimmune disease\n8. Diabetes treated with insulin\n9. Severe systemic illness or severe medical conditions such as cardiovascular or lung diseases\n10. Medication with beta blockers\n11. Medication with ACE-inhibitors\n12. Mastocytosis\n13. Pregnancy or breastfeeding\n14. Language barriers (not fluent Finnish or Swedish)","17 Years",{"count":21,"type":22},[59],"NA","Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to cashew nuts among young children. Of the food anaphylaxis cases reported in the Finnish Anaphylaxis Registry between 2015-2020, 49% were caused by nuts, with cashew nuts being the most common trigger. The standard treatment for nut allergies is strict avoidance of nuts and symptom management with emergency medications.\n\nOral immunotherapy (OIT) is a food allergy treatment that increases tolerance, and it has primarily been studied in school-aged children, with desensitization achieved in about 80% of cases. Permanent tolerance, depending on the allergen, develops in 30-50% of cases within five years. International guidelines recommend peanut OIT for children over the age of 4 who have severe peanut allergies. The likelihood of achieving tolerance, especially permanent tolerance, appears to improve the earlier the treatment is started. To date, only one study (NUIT CRACKER) has been published on cashew nut desensitization in children over 4 years old, involving 50 children, where 88% achieved desensitization to both cashew nuts and pistachios.\n\nThe aim of this study is to develop a cashew nut desensitization protocol and investigate its effectiveness in achieving tolerance and permanent desensitization in children aged 1-17 years, compared to cashew nut avoidance. The study will assess the safety of cashew nut desensitization and its impact on the quality of life of patients and their families.",[62,63,28],"Oral Immunotherapy for Food Allergy","Tree Nut Allergy",[65,66,67,68],"Oral immunotherapy","Cashew","Tree Nut","Food allergen immunotherapy","RECRUITING","2025-04-09",{"date":72,"type":40},"2025-04-16",{"date":74,"type":40},"2024-09-13",{"date":76,"type":22},"2029-11-05",{"name":78,"class":47},"HUS Skin and Allergy Hospital"]