[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652017":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":103,"collaborators":107,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":18,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":18,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":140,"whyStopped":18,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral immunotherapy","EXPERIMENTAL","Children randomized to oral immunotherapy will ingest a daily dose of cow's milk. Dose escalation will be performed approximately every two weeks at the allergy clinic or via online consultations. After approximately 6 months, a maintenance dose of 300 mg food protein will be reached and continued daily for 6-12 months.",[13],"Other: Oral immunotherapy with cow's milk",{"label":15,"type":16,"description":17,"interventionNames":18},"Avoidance","NO_INTERVENTION","Children randomized to avoidance will receive standard care for cow's milk allergy, including avoidance of cow's milk.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Oral immunotherapy with cow's milk","Oral immunotherapy with cow's milk for 1-1.5 years",[9],[25],{"name":26,"affiliation":27,"role":28},"Laura O Kettner, MD, PhD","The Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+45 51703229","lauchr@rm.dk",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Sune LM Rubak, MD, PhD","+45 51729258","sunerubak@skejby.rm.dk",[39,53,66,79,91],{"facility":40,"status":18,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital","Aarhus","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],10.21076,56.15674,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":32,"phoneExt":18,"email":33},"Laura O Kettner",{"facility":54,"status":18,"city":55,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Regional Hospital Gødstrup","Gødstrup",{"type":45,"coordinates":57},[58,59],8.89276,56.15584,{"lat":59,"lon":58},[62],{"name":63,"role":31,"phone":64,"phoneExt":18,"email":65},"Anette Flugt","+45 78430355","aneflu@rm.dk",{"facility":67,"status":18,"city":68,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Regional Hospital Kolding","Kolding",{"type":45,"coordinates":70},[71,72],9.47216,55.4904,{"lat":72,"lon":71},[75],{"name":76,"role":31,"phone":77,"phoneExt":18,"email":78},"Signe V Vahlkvist","+45 76363341","Signe.Vahlkvist@rsyd.dk",{"facility":80,"status":18,"city":81,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Regional Hospital Randers","Randers",{"type":45,"coordinates":83},[84,85],10.03639,56.4607,{"lat":85,"lon":84},[88],{"name":89,"role":31,"phone":18,"phoneExt":18,"email":90},"Lotte Abildgaard","LOTABI@rm.dk",{"facility":92,"status":18,"city":93,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Regional Hospital Viborg","Viborg",{"type":45,"coordinates":95},[96,97],9.40201,56.45319,{"lat":97,"lon":96},[100],{"name":101,"role":31,"phone":18,"phoneExt":18,"email":102},"Birgitte T Petersen","Birgitte.Petersen@midt.rm.dk",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Laura Ozer Kettner","Doctor",[108,110,112,114],{"name":109,"class":6},"Randers Regional Hospital",{"name":111,"class":6},"Gødstrup Hospital",{"name":113,"class":6},"Viborg Regional Hospital",{"name":115,"class":6},"Kolding Sygehus","100652017","oral-immunotherapy-for-children-with-cows-milk-allergy-100652017",false,"NCT07768696","Oral Immunotherapy for Children With Cow's Milk Allergy","Oral Immunotherapy for Children With Cow's Milk Allergy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 6 to 18 months\n* Cow's milk allergy confirmed at an oral food challenge\n* Reaction threshold below 300 mg of cow's milk protein at the oral food challenge\n* Specific IgE to cow's milk \\> 0.35 kU\u002FL\n* High risk of persistent allergy to cow's milk (based on defined criteria)\n* Family motivated for oral immunotherapy following shared decision-making using a decision aid\n\nExclusion Criteria:\n\n* Uncontrolled asthma, eczema, rhino-conjunctivitis, urticaria, or eosinophilic esophagitis\n* Treatment with biologic or immunosuppressive medication\n* Non-Danish-speaking families\n* Anticipated non-adherent families","ALL","6 Months","18 Months",{"count":127,"type":128},56,"ESTIMATED","INTERVENTIONAL",[131],"NA","This clinical trial aims to investigate if oral immunotherapy can help children with cow's milk allergy tolerate cow's milk.\n\nChildren aged 6-18 months can take part in the trial.\n\nMain question: What percentage of children can tolerate cow's milk after oral immunotherapy, compared with children who avoid cow's milk?\n\nChildren are assigned to these two groups by chance.\n\nChildren receiving oral immunotherapy will:\n\n* Take a small, increasing amount of cow's milk daily for 1-1.5 years\n* Attend clinic or online visits each time the dose is increased\n* Record missed doses\n\nAll children will:\n\n* Provide blood samples to measure allergy-related markers\n* Undergo an oral food challenge with cow's milk after 1-1.5 years to assess how much they can tolerate\n* Report allergic reactions (parent-reported)\n* Complete questionnaires (parent-reported)\n* Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)",[134,135,136],"Milk Allergy, Cow's","Food Allergy in Children","Food Allergies",[9,138,139],"OIT","Desensitization","NOT_YET_RECRUITING","2026-08-12",{"date":143,"type":144},"2026-08-17","ACTUAL",{"date":146,"type":128},"2026-09",{"date":148,"type":128},"2031-09",{"name":105,"class":6},5]