[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cow-milk-allergy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cow-milk-allergy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28],"Food Allergy","Cow Milk Allergy","RECRUITING","2026-05-04",{"date":32,"type":33},"2026-05-08","ACTUAL",{"date":35,"type":33},"2024-04-22",{"date":37,"type":21},"2029-12-30",{"name":39,"class":40},"Universitaire Ziekenhuizen KU Leuven","OTHER",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100567187","effectiveness-and-safety-of-milk-ladders-in-children-with-ige-mediated-cows-milk-protein-allergy-100567187","NCT06664918","Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy","Effectiveness and Safety of the 4-Step Versus 6-Step Milk Ladder in Children with IgE-Mediated Cow's Milk Protein Allergy: Protocol for an Open-Label Randomised Controlled Trial","Inclusion Criteria:\n\n* Age between 1 and 5 years.\n* Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis), diagnosis based on positive skin prick testing and\u002For elevated specific IgE to CMPs is sufficient.\n* On a therapeutic elimination diet for at least 6 months or up to 12 months of age.12\n* Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.\n* Good overall health status.\n* Parents without language barriers.\n* Written informed consent signed by parents.\n* Good cooperation with the child's guardians.\n\nExclusion Criteria:\n\n* Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough, and\u002For auscultatory changes despite treatment.\n* Signs of exacerbation of a chronic disease.\n* Signs of acute infectious disease (i.e., acute runny nose, cough, subfebrile fever, or fever).\n* Signs of exacerbation of another allergic disease (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).\n* Anaphylaxis due to CMPs in the last 6 months.\n* Used antihistamines within 3-10 days before the challenge (depending on the characteristics of the drug and the reason for use).\n* Acquired tolerance to baked CMPs or higher steps of the milk ladder.\n* Use of immunosuppressive drugs or immunotherapy","5 Years",{"count":51,"type":21},92,[24],"Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.\n\nAvailable data from the literature indicate that most children with CMPA acquire tolerance to CMPs with age. An assessment of tolerance acquisition to CMPs is commonly performed using milk ladder. However, scientific evidence regarding the effectiveness and safety of the milk ladder in children with CMPA is limited. Currently, there is no standardised milk ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries.\n\nThis study aims to assess the effectiveness and safety of the 4-step milk ladder (4-ML) compared to the 6-step milk ladder (6-ML) in children with IgE-mediated CMPA. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.",[28,27],[56,57,58],"IgE-mediated cow's milk allergy","children","milk ladder","2025-03-13",{"date":61,"type":33},"2025-03-18",{"date":63,"type":33},"2024-12-03",{"date":65,"type":21},"2029-03",{"name":67,"class":40},"Medical University of Warsaw",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100499595","clinical-versus-home-introduction-of-milk-in-children-with-non-ige-mediated-cows-milk-allergy-100499595","NCT05785299","Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy","Evaluation of the Outcome of Clinical or Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy (ENIGMA Trial)","ENIGMA","Inclusion Criteria:\n\n* maximum age of eighteen months;\n* suspected to be allergic for cow's milk (based on medical history);\n\nExclusion Criteria:\n\n* children older than the age of eighteen months;\n* sensitised for cow's milk (i.e. SPT \\>3mm (in combination with positive control ≥3mm) or specific IgE \\>0.35 kU\u002FL)\n* patient suffers from acute (i.e. within one hour after cow's milk had been eaten) and moderate-severe IgE-mediated symptoms after ingestion of cow's milk\n* patient suffers from symptoms according to the FPIES criteria after ingestion of cow's milk\n* patient uses beta blockers and\u002For prednisolone;\n* patient suffers from uncontrolled respiratory symptoms or severe eczema or a chronic condition because of which the patients cannot be included as judged by the treating physician;\n* parents are unable to adequately report the occurrence of possible symptoms (e.g. insufficient language proficiency).","1 Month","18 Months",{"count":80,"type":21},120,[24],"There are a lot of parents who believe that their child may not tolerate cow's milk because they develop symptoms such as redness of the skin or they may vomit. It is not always easy to find out if these infants should indeed avoid drinking cow's milk or that the symptoms are caused by something else, for instance because they have a viral illness. The goal of the investigators is to find out if cow's milk should be introduced in the hospital or if it can also be advised to perform the introduction at home to determine if an infant can drink cow's milk without developing symptoms. Half of the participants will drink cow's milk in the hospital. This test is performed on two days. On one of the days cow's milk will be offered. On the other day a look-alike substance is offered. The other half of the participants will drink cow's milk at home by starting to drink a little bit of milk and in a few steps drink a normal bottle of cow's milk. The main question is whether both tests can be used to find out if an infant can drink cow's milk without developing symptoms.",[28,27],"2024-11-21",{"date":86,"type":33},"2024-11-25",{"date":88,"type":33},"2023-10-09",{"date":90,"type":21},"2026-06-01",{"name":92,"class":40},"Martini Hospital Groningen",1]