protocolSection identificationModule nctId: NCT06380673, orgStudyIdInfo id: s68299, briefTitle: Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy, acronym: TEHITI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2028-12-30, completionDateStruct date: 2029-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Food Allergy, conditions: Cow Milk Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Implementation of cow's milk in decreasingly heated forms, interventions name: Implementation of heated cow's milk, interventions name: No intervention, outcomesModule primaryOutcomes measure: Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction, secondaryOutcomes measure: Time to complete tolerance in all three arms, secondaryOutcomes measure: Quality of life in all three arms, secondaryOutcomes measure: Clinical reactions, secondaryOutcomes measure: Side effects, secondaryOutcomes measure: IL-10-producing cow's milk specific regulatory T and B cells, secondaryOutcomes measure: BATs to mimic the outcome of cow's milk provocation tests, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Imelda Hospital Bonheiden, status: RECRUITING, city: Bonheiden, country: Belgium, contacts name: Katrien Coppens, MD, role: CONTACT, geoPoint lat: 51.02261, lon: 4.54714, locations facility: AZ Sint-Jan, status: RECRUITING, city: Brugge, country: Belgium, contacts name: Kate Sauer, MD, role: CONTACT, geoPoint lat: 51.20892, lon: 3.22424, locations facility: AZ Maria Middelares, status: RECRUITING, city: Ghent, country: Belgium, contacts name: Jasmine Leus, MD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: Jessa Hospital, status: RECRUITING, city: Hasselt, country: Belgium, contacts name: Sophie Verelst, MD, role: CONTACT, geoPoint lat: 50.93106, lon: 5.33781, locations facility: UZ Leuven Gasthuisberg, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Dominique MA Bullens, Prof. Dr., role: CONTACT, phone: +32016343801, email: dominique.bullens@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False