[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627446":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":17,"interventions":17,"overallOfficials":23,"centralContacts":37,"locations":46,"responsibleParty":102,"collaborators":105,"id":111,"slug":17,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":123,"studyType":124,"phases":17,"briefSummary":125,"conditions":126,"keywords":17,"overallStatus":49,"whyStopped":17,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants that acquire tolerance for cow's milk after initially failing a cow's milk provocation test","The number of participants that spontaneously acquire tolerance for cow's milk after initially failing a cow's milk provocation test will be counted.","48 months",[14],{"measure":15,"description":16,"timeFrame":12},"Adverse clinical reactions to cow's milk protein intake during observational period","Nature and condition of clinical reactions in relation to different heated and\u002For unheated forms of cow's milk protein intake during observational period",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","In this observational study the investigators will study the time to complete tolerance in cow's milk allergic children who tolerate 20' heated milk but failed the OFC with unheated milk 12 months after passing the 20' boiled cow's milk OFC. Moreoever, the investigators want to document all clinical reactions and potential cofactors during the tolerance induction process. The investigators anticipate that the whole cohort will become tolerant in a time span shorter than 48 months. Therefore the study period in each participant will be 48 months or the period to achieve complete tolerance (which comes first).","Children participating in study s68299 who fail the challenge test with unheated cow's milk 12 months after initiation of the TEHITI trial, can be enrolled in this post-TEHITI study. Upon IC (and assent if appropriate) parents (and children) can participate in the current post-TEHITI observational trial. Upon enrollment in the post-TEHITI trial, specific data will be pseudonymised and collected during the clinical follow-up visits:\n\n* Intake of cow's milk containing food products: amount, recipe, frequency of intake in the period between two follow-up consultations\n* Clinical reactions: description and recording of potential cofactors for their presentation\n* Medication use to treat the clinical reaction\n* Relation to cow's milk intake: certain\u002Fdoubtful\u002Fabsent\n* Specific IgE to cow's milk proteins in peripheral blood\n* Total IgE levels in peripheral blood Individual pseudonymisation will be done by similar code as given in TEHITI trial.",[24,28,31,34],{"name":25,"affiliation":26,"role":27},"Jasmine Leus, MD","Maria Middelares Hospital, Gent","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Katrien Coppens, MD","Imelda Hospital, Bonheiden",{"name":32,"affiliation":33,"role":27},"Sophie Verelst, MD","Jessa Hospital, Hasselt and KU Leuven",{"name":35,"affiliation":36,"role":27},"Kate Sauer, MD","AZ Sint-Jan AV",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":17,"email":42},"Dominique MA Bullens, Prof, MD","CONTACT","+32016343801","dominique.bullens@uzleuven.be",{"name":44,"role":40,"phone":41,"phoneExt":17,"email":45},"Marleen Jannis","marleen.jannis@uzleuven.be",[47,61,71,81,91],{"facility":48,"status":49,"city":50,"state":17,"zip":17,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Imelda Hospital","RECRUITING","Bonheiden","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],4.54714,51.02261,{"lat":57,"lon":56},[60],{"name":29,"role":40,"phone":17,"phoneExt":17,"email":17},{"facility":62,"status":49,"city":63,"state":17,"zip":17,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"AZ Sint Jan","Bruges",{"type":54,"coordinates":65},[66,67],3.22424,51.20892,{"lat":67,"lon":66},[70],{"name":35,"role":40,"phone":17,"phoneExt":17,"email":17},{"facility":72,"status":49,"city":73,"state":17,"zip":17,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"AZ Maria Middelares","Ghent",{"type":54,"coordinates":75},[76,77],3.71667,51.05,{"lat":77,"lon":76},[80],{"name":25,"role":40,"phone":17,"phoneExt":17,"email":17},{"facility":82,"status":49,"city":83,"state":17,"zip":17,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Jessa Hospital","Hasselt",{"type":54,"coordinates":85},[86,87],5.33781,50.93106,{"lat":87,"lon":86},[90],{"name":32,"role":40,"phone":17,"phoneExt":17,"email":17},{"facility":92,"status":49,"city":93,"state":17,"zip":17,"country":51,"countryCode":52,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"UZ Leuven Gasthuisberg","Leuven",{"type":54,"coordinates":95},[96,97],4.70093,50.87959,{"lat":97,"lon":96},[100,101],{"name":39,"role":40,"phone":17,"phoneExt":17,"email":17},{"name":44,"role":40,"phone":41,"phoneExt":17,"email":45},{"type":27,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Dominque Bullens","Dominique MA Bullens, MD PhD",[106,107,108,110],{"name":82,"class":6},{"name":30,"class":6},{"name":109,"class":6},"Algemeen Ziekenhuis Maria Middelares",{"name":36,"class":6},"100627446",false,"NCT07448740","Post-failure Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Cow's Milk Allergy Observational Cohort Study","Post-TEHITI","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n* participation in s68299\n* failure to challenge test with unheated cow's milk\n* passed challenge test with unheated cow's milk but with symptoms developing between challenge and termination visit related to cow's milk intake at home\n\nExclusion Criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\n* Subjects not priorly enrolled in s68299\n* Subjects enrolled in s68299 who passed the challenge test and have no complaints upon regular cow's milk consumption at termination visit\n* Subjects who refuse to consent\u002Fassent with the study","ALL","1 Year","18 Years",{"count":121,"type":122},30,"ESTIMATED","48 Months","OBSERVATIONAL","Subjects who failed to become tolerant within 12 months after randomization within one of the three arms in the TEHITI study, can participate in the post-TEHITI observational trial to study the natural tolerance induction process.",[127],"Cow's Milk Protein Allergy","2026-02-28",{"date":130,"type":131},"2026-03-04","ACTUAL",{"date":133,"type":131},"2025-03-31",{"date":135,"type":122},"2030-10-24",{"name":5,"class":6},5]