[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557080":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":18,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Allergic children - Multiallergen OIT","ACTIVE_COMPARATOR","Children with food allergy receiving multiallergen powder OIT. Multiallergen food challenge is done before randomization and one and two years after inclusion. OIT multiallergen powder with slow up-dosing until 3 teaspoons of the multiallergen powder is reached and taken daily. 2 years treatment.\n\nNumber = 40 patients\n\nIntervention: multiallergen powder",[13],"Dietary Supplement: Multiallergen powder",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Allergic children - Placebo powder","NO_INTERVENTION","Children with food allergy receiving OIT with placebo powder (gluten-free oatmeal). Multiallergen food challenge is done before randomization and one and two years after inclusion.\n\nNumber = 40 patients",null,{"label":20,"type":10,"description":21,"interventionNames":22},"Group C: Non-allergic children - low dose multiallergen powder","Children not reacting to the baseline challenge who will be randomized to eat a low dose of the multiallergen powder, 1 teaspoon daily. Multiallergen food challenge is done before randomization and one year after inclusion. 1 year treatment.\n\nNumber = X\n\nIntervention: Multiallergen powder",[13],{"label":24,"type":16,"description":25,"interventionNames":18},"Group D: Non-allergic children - placebo powder","Children not reacting to the baseline challenge who will be randomized to eat placebo powder (gluten-free oatmeal) and no specific advice.\n\nNumber= X",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":18},"DIETARY_SUPPLEMENT","Multiallergen powder","OIT multiallergen powder.",[9,20],[33,36],{"name":34,"affiliation":5,"role":35},"Caroline Nilsson, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":5,"role":35},"Anna Asarnoj, MD, PhD",[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Idun Holmdahl, MD, PhD","CONTACT","+46703002279","idun.holmdahl@ki.se",[45],{"facility":46,"status":47,"city":48,"state":18,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Södersjukhuset","RECRUITING","Stockholm","11883","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],18.06871,59.32938,{"lat":56,"lon":55},[59],{"name":40,"role":41,"phone":60,"phoneExt":18,"email":43},"00460812364037",{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Idun Holmdahl","Pediatrician, Postdoctoral researcher","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":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83,84],"Food Allergy","Oral Immunotherapy for Food Allergy","2025-09-09",{"date":87,"type":88},"2025-09-16","ACTUAL",{"date":90,"type":88},"2024-11-08",{"date":92,"type":77},"2027-12",{"name":5,"class":6},1]