[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-immunotherapy-for-food-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-immunotherapy-for-food-allergy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651607","multi-food-oral-immunotherapy-for-peanut-and-tree-nuts-100651607",false,"NCT07764159","Multi-Food Oral Immunotherapy for Peanut and Tree Nuts","An Open-Label, Multicenter, Randomized Clinical Trial Evaluating the Efficacy and Safety of Oral Multi-Food Immunotherapy With Peanut and Tree Nuts Protein Mixtures","Inclusion Criteria:\n\n* Age 1-12 years;\n* Confirmed allergy to at least two allergens included in the protocol, i.e., peanut and\u002For tree nuts: cashew, walnut, hazelnut, and almond;\n* Positive skin prick test (SPT) (wheal diameter ≥ 3 mm) and\u002For specific IgE (sIgE) level \\> 0.35 kUA\u002FL for at least two of the analyzed allergens;\n* Positive OFC-1 (oral food challenge) of grade I-IV according to the WAO classification for at least two allergens, with a positive reaction occurring after administration of a dose ≥ 3 mg and ≤ 3000 mg of allergen protein;\n* Participants may be enrolled based on the abbreviated procedure as outlined in the study description;\n* Written informed consent obtained from a legal guardian, and, where applicable, assent from the child in accordance with their age and level of maturity;\n* Good prognosis for compliance and cooperation of the patient and their caregivers.\n\nExclusion Criteria:\n\n* Allergic reaction at the lowest challenge dose of 1 mg of allergen protein for any allergen, or no allergic reaction after administration of the maximum dose of 3000 mg of allergen protein for at least four of the analyzed allergens;\n* History of anaphylaxis with a grade V reaction according to the WAO classification, either during an oral food challenge or in the patient's medical history;\n* Severe asthma;\n* Poorly controlled asthma according to GINA 2025 (lack of symptom control and\u002For ≥2 exacerbations requiring systemic glucocorticoids or ≥1 exacerbation requiring hospitalization within the last 12 months), or in children able to perform spirometry: FEV1 \\\u003C -1.64 Z-score and\u002For FEV1\u002FFVC \\\u003C -1.64 Z-score;\n* Eosinophilic gastrointestinal disease;\n* Other chronic diseases requiring ongoing treatment which, in the investigator's opinion, may increase the risk associated with study participation or interfere with the interpretation of results, including severe cardiac disease, epilepsy, metabolic disorders, or diabetes;\n* Previous immunotherapy with food allergens;\n* Concurrent immunotherapy with aeroallergens;\n* Treatment with biologic agents, beta-blockers, ACE inhibitors, or calcium channel blockers;\n* Oral corticosteroid therapy meeting any of the following criteria: daily treatment for \\>1 month within the last 12 months; at least two courses lasting ≥7 days within the last 12 months; one course lasting ≥7 days within the last 3 months;\n* Lack of consent to participate in the study or insufficient cooperation of the patient and\u002For caregivers. In such cases, patients will receive standard medical care, including allergen avoidance and provision of emergency medication.\n\nWell-controlled asthma, allergic rhinitis, and atopic dermatitis are not exclusion criteria.","ALL","1 Year","12 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.",[27,28,29,30,31],"Food Allergies","Food Allergy in Children","Peanut Allergies","Tree Nut Allergies","Oral Immunotherapy for Food Allergy","NOT_YET_RECRUITING","2026-08-11",{"date":35,"type":36},"2026-08-13","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2031-12",{"name":42,"class":43},"Medical University of Warsaw","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100557080","randomized-controlled-trial-of-slow-multiallergen-oral-immunotherapy-in-young-children-100557080","NCT06533462","Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children","Infant Food Allergen Oral Immunotherapy (InFO)","InFO","Inclusion Criteria:\n\n* 0.5-3 years old at inclusion with IgE (\\>0.1 kUA\u002Fl) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew).\n* Written consent for participation in the study for both guardians.\n* 80 children (group A and B) also need a positive baseline food challenge.\n* Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.\n\nExclusion Criteria:\n\n* other serious illness\n* previous life-threatening anaphylaxis (intensive care)\n* eosinophilic esophagitis\n* eosinophilic gastrointestinal disease\n* severe chronic gastroesophageal reflux disease\n* unclear recurrent GI complaints\n* low body weight \\\u003C2SD\n* participation in another intervention study if included in intervention group\n* severe uncontrolled asthma\n* medication with biological drugs or oral steroids.","6 Months","3 Years",{"count":56,"type":21},80,[24],"The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a method to cure food allergy and to prevent the development of new food allergies.\n\nClinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B).\n\nAmong 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B).\n\nA sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.",[60,31],"Food Allergy","RECRUITING","2025-09-09",{"date":64,"type":36},"2025-09-16",{"date":66,"type":36},"2024-11-08",{"date":68,"type":21},"2027-12",{"name":70,"class":43},"Karolinska Institutet",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":71},"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":81,"type":21},45,[24],"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.",[31,85,86],"Tree Nut Allergy","Cashew Nut Allergy",[88,89,90,91],"Oral immunotherapy","Cashew","Tree Nut","Food allergen immunotherapy","2025-04-09",{"date":94,"type":36},"2025-04-16",{"date":96,"type":36},"2024-09-13",{"date":98,"type":21},"2029-11-05",{"name":100,"class":43},"HUS Skin and Allergy Hospital"]