[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545343":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":55,"locations":64,"responsibleParty":120,"collaborators":32,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":32,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":32,"overallStatus":67,"whyStopped":32,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,13,17,22],{"label":9,"type":6,"description":10,"interventionNames":11},"Stepwise introduction using gradually shorter heating of cow's milk proteins","Step 1: open introduction of 20' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months.\n\nStep 2: open introduction of 15' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months.\n\nStep 3: open introduction of 10' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months.\n\nStep 4: open introduction of 5' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 3 months.",[12],"Other: Implementation of cow's milk in decreasingly heated forms",{"label":14,"type":6,"description":15,"interventionNames":16},"Stepwise introduction using the Flemish Milk Ladder","The first 5 steps of the Flemish Milk Ladder (each containing a, b and c part) will be gradually introduced at home, each step for 21 days (2-3X a week during 3 consecutive weeks after which 3 days \"rest\"). We consider the 6th step the equivalent of tolerance induction so step 6 will be allowed once the OFC with uncooked milk is passed.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Control arm with introduction of 20' cooked cow's milk","Step 1: open introduction of 20' cooked cow's milk (at least 10 mL per portion, 2-3X a week) for 12 months.",[21],"Other: Implementation of heated cow's milk",{"label":23,"type":6,"description":24,"interventionNames":25},"Healthy age-matched subjects","For work package 2, 15 healthy age-matched subjects are included to compare immunological mechanisms with.",[26],"Other: No intervention",[28,33,37],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Implementation of cow's milk in decreasingly heated forms","Implementation of cow's milk in decreasingly heated forms in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.",[9,14],null,{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Implementation of heated cow's milk","Implementation of heated cow's milk in cow's milk allergic subjects, tolerant to heated cow's milk, to assess the influence on tolerance induction.",[18],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"No intervention","Healthy subjects undergo no intervention.",[23],[42,46,49,52],{"name":43,"affiliation":44,"role":45},"Jasmine Leus, MD","Maria Middelares Hospital, Gent","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":45},"Katrien Coppens, MD","Imelda Hospital, Bonheiden",{"name":50,"affiliation":51,"role":45},"Sophie Verelst, MD","KU Leuven and Jessa Hospital, Hasselt",{"name":53,"affiliation":54,"role":45},"Kate Sauer, MD","AZ Sint-Jan AV",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":32,"email":60},"Dominique MA Bullens, Prof. MD","CONTACT","+32016343801","dominique.bullens@kuleuven.be",{"name":62,"role":58,"phone":59,"phoneExt":32,"email":63},"Marleen Jannis","marleen.jannis@uzleuven.be",[65,79,89,99,109],{"facility":66,"status":67,"city":68,"state":32,"zip":32,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Imelda Hospital Bonheiden","RECRUITING","Bonheiden","Belgium","BE",{"type":72,"coordinates":73},"Point",[74,75],4.54714,51.02261,{"lat":75,"lon":74},[78],{"name":47,"role":58,"phone":32,"phoneExt":32,"email":32},{"facility":80,"status":67,"city":81,"state":32,"zip":32,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"AZ Sint-Jan","Bruges",{"type":72,"coordinates":83},[84,85],3.22424,51.20892,{"lat":85,"lon":84},[88],{"name":53,"role":58,"phone":32,"phoneExt":32,"email":32},{"facility":90,"status":67,"city":91,"state":32,"zip":32,"country":69,"countryCode":70,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"AZ Maria Middelares","Ghent",{"type":72,"coordinates":93},[94,95],3.71667,51.05,{"lat":95,"lon":94},[98],{"name":43,"role":58,"phone":32,"phoneExt":32,"email":32},{"facility":100,"status":67,"city":101,"state":32,"zip":32,"country":69,"countryCode":70,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Jessa Hospital","Hasselt",{"type":72,"coordinates":103},[104,105],5.33781,50.93106,{"lat":105,"lon":104},[108],{"name":50,"role":58,"phone":32,"phoneExt":32,"email":32},{"facility":110,"status":67,"city":111,"state":32,"zip":32,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"UZ Leuven Gasthuisberg","Leuven",{"type":72,"coordinates":113},[114,115],4.70093,50.87959,{"lat":115,"lon":114},[118],{"name":119,"role":58,"phone":59,"phoneExt":32,"email":60},"Dominique MA Bullens, Prof. Dr.",{"type":45,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Dominque Bullens","Clinic Head in Pediatrics-Allergy at UZ Leuven, Head of the Allergy and Clinical Immunology Research group at KU Leuven (prof., dr.)","100545343","stepwise-heat-denaturated-protein-introduction-for-tolerance-induction-in-food-allergy-100545343",false,"NCT06380673","Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy","TEHITI","Inclusion Criteria:\n\n* Children (1-18y) had or have a clinical diagnosis of IgE mediated cow's milk allergy based on positive history as well as skin prick testing and\u002For specific IgE detection by CAPtest in an allergy clinic.\n* Children are at least 12 months old before introduction of heated cow's milk is considered.\n* Children did not suffer from grade 4 anaphylaxis due to cow's milk-ingestion at presentation.\n* Children have specific IgE levels to Bos d 8 below 1.2 kU\u002FmL and\u002For children passed 20' cooked cow's milk provocation test executed on clinical judgement.\n\nExclusion Criteria:\n\n* Children had grade 4 anaphylaxis due to cow's milk ingestion.\n* Children are younger than 12 months old at the moment of passing 20' cooked cow's milk OFC.\n* Parents are not able or not willing to adhere to a specific cow's milk protein-containing diet on a regular basis at home.\n* Multiple food allergy, not compatible with any of the choices in the Flemish Milk Ladder.\n* Parents and\u002For children are not willing to give IC\u002Fassent.","ALL","1 Year","18 Years",{"count":134,"type":135},90,"ESTIMATED","INTERVENTIONAL",[138],"NA","This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only).",[141,142],"Food Allergy","Cow Milk Allergy","2026-05-04",{"date":145,"type":146},"2026-05-08","ACTUAL",{"date":148,"type":146},"2024-04-22",{"date":150,"type":135},"2029-12-30",{"name":5,"class":6},5]