[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100557080","randomized-controlled-trial-of-slow-multiallergen-oral-immunotherapy-in-young-children-100557080",false,"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.","ALL","6 Months","3 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Food Allergy","Oral Immunotherapy for Food Allergy","RECRUITING","2025-09-09",{"date":33,"type":34},"2025-09-16","ACTUAL",{"date":36,"type":34},"2024-11-08",{"date":38,"type":22},"2027-12",{"name":40,"class":41},"Karolinska Institutet","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"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)","1 Year","17 Years",{"count":53,"type":22},45,[25],"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.",[29,57,58],"Tree Nut Allergy","Cashew Nut Allergy",[60,61,62,63],"Oral immunotherapy","Cashew","Tree Nut","Food allergen immunotherapy","2025-04-09",{"date":66,"type":34},"2025-04-16",{"date":68,"type":34},"2024-09-13",{"date":70,"type":22},"2029-11-05",{"name":72,"class":41},"HUS Skin and Allergy Hospital"]