[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596027":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":39,"locations":48,"responsibleParty":72,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"4-Step Egg Ladder","EXPERIMENTAL",null,[13],"Other: oral food challenge (OFC)",{"label":15,"type":16,"description":11,"interventionNames":17},"5-Step Egg Ladder","ACTIVE_COMPARATOR",[13],[19,23],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"oral food challenge (OFC)","oral food challenges with subsequent steps of a 4-step egg ladder (muffin \\[1.5 g of hen's egg protein per portion\\], pancake, hard-boiled egg, soft-boiled egg)",[9],{"type":6,"name":20,"description":24,"armGroupLabels":25,"otherNames":11},"oral food challenges with subsequent steps of a 5-step egg ladder (muffin \\[0.75 g of hen's egg protein per portion\\], muffin \\[1.5 g of hen's egg protein per portion\\], pancake, hard-boiled egg, soft-boiled egg)",[15],[27,30,33,36],{"name":28,"affiliation":5,"role":29},"Hanna Szajewska, MD, Professor","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Anna Nowak-Węgrzyn, MD, Professor","Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine",{"name":34,"affiliation":35,"role":29},"Andrea Horvath, MD, PhD","Medical Univeristy of Warsaw",{"name":37,"affiliation":38,"role":29},"Joanna Jerzyńska, MD, PhD","Medical Univeristy of Lodz",[40,44],{"name":34,"role":41,"phone":42,"phoneExt":11,"email":43},"CONTACT","048 22 317 94 44","andrea.horvath@wum.edu.pl",{"name":45,"role":41,"phone":46,"phoneExt":11,"email":47},"Maria Zemla, MD","048 602 850 070","maria.zemla@wum.edu.pl",[49,64],{"facility":50,"status":11,"city":51,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Medical Univeristy of Warsaw, Department of Paediatrics","Warsaw","Poland","PL",{"type":55,"coordinates":56},"Point",[57,58],21.01178,52.22977,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":11,"email":47},"Maria Zemla","602 850 070",{"facility":35,"status":11,"city":51,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},{"type":55,"coordinates":66},[57,58],{"lat":58,"lon":57},[69],{"name":70,"role":41,"phone":71,"phoneExt":11,"email":43},"Andrea Horvath, MD PhD","22 317 94 44",{"type":29,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Andrea Horvath-Stolarczyk","Associate Professor","100596027","efficacy-and-safety-of-egg-ladders-in-children-with-ige-mediated-hens-egg-protein-allergy-100596027",false,"NCT07040111","Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy","Efficacy and Safety of a 4-Step Versus a 5-Step Egg Ladder in Children With IgE-Mediated Hen's Egg Protein Allergy: Protocol for an Open-Label Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 12 months and ≤ 5 years.\n* Diagnosis of IgE-mediated HEA confirmed according to the EAACI guidelines by a positive OFC with hen's egg proteins. In children with high-risk HEA (e.g., history of anaphylaxis), diagnosis can be based on elevated specific IgE levels (3.5 kU\u002Fl) to hen's egg proteins and\u002For individual egg components and\u002For positive skin tests.\n* On a therapeutic elimination diet for at least 6 months, measured from the last allergic reaction to egg (in accordance with BSACI guidelines).\n* Eligible regardless of the risk of systemic reactions (e.g. anaphylaxis) or asthma.\n* Good general health.\n* Written informed consent signed by the child's guardians.\n* Demonstrated good cooperation from the patient's guardians.\n\nExclusion Criteria:\n\n* Confirmed wheat allergy and\u002For celiac disease.\n* Uncontrolled asthma, defined as the presence of shortness of breath, cough, chest tightness, or auscultatory changes despite treatment.\n* Signs of exacerbation of a chronic disease.\n* Signs of acute infectious disease (e.g. acute rhinitis, cough, subfebrile or febrile states).\n* Signs of exacerbation of another allergic disease (e.g., conjunctivitis, allergic rhinitis, atopic dermatitis).\n* Anaphylaxis due to hen's egg proteins within the last 6 months.\n* Use of antihistamines within 3-10 days before the challenge (depending on the drug and indication; time-limited contradiction - relative exclusion criterion).\n* Acquired tolerance to baked hen's egg proteins or advancement to a higher step of the egg ladder.\n* Use of immunosuppressive drugs or immunotherapy.","ALL","1 Year","5 Years",{"count":86,"type":87},94,"ESTIMATED","INTERVENTIONAL",[90],"NA","Hen's Egg Allergy is one of the most common food allergies in early childhood. The first-line treatment is the elimination of hen's egg proteins from the child's or maternal diet.\n\nAvailable data from the literature indicate that most children with hen's egg allergy acquire tolerance to hen's egg proteins with age. An assessment of tolerance acquisition to them is commonly performed using egg ladder. However, scientific evidence regarding the effectiveness and safety of the egg ladder in children with hen's egg allergy is limited. Currently, there is no standardised egg 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 egg ladder (4-EL) compared to the 5-step egg ladder (5-EL) in children with IgE-mediated hen's egg allergy. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.",[93,94,95],"Food Allergy","Egg Allergy","Hen Egg Allergy",[97,98,99],"children","egg ladder","IgE-mediated hen egg allergy","NOT_YET_RECRUITING","2025-06-26",{"date":103,"type":104},"2025-07-01","ACTUAL",{"date":106,"type":87},"2025-07",{"date":108,"type":87},"2028-11",{"name":5,"class":6},2]