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Randomized Controlled Trial for Wheat Oral Immunotherapy

RecruitingNAAges 1 Year - 17 YearsAllChinese University of Hong Kong
NCT06069492 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

IgE-mediated wheat allergy is a growing allergy problem in children, and affected children can predict with immediate-type allergic reactions to the extent of anaphylactic shock. Current diagnostic methods based on crude wheat extract are inaccurate and unreliable. Besides, these children are managed by a passive "wait-and-see" approach that reflect the natural history of wheat allergy. Nonetheless, a significant proportion of wheat-allergic children have persistent disease until school-age and adolescence. There is an unmet need for designing effective and safe immunotherapeutic strategy for wheat allergy. This study aims to investigate performance of allergy tests based on crude wheat and wheat allergens as measured using both quantitative and functional IgE-based assays for diagnosing IgE-mediated wheat allergy; and to compare efficacy and safety of different dosages of wheat oral imm

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📋 Eligibility rules (as published)
Inclusion Criteria: First stage to diagnose immediate-type wheat allergy: * 1-17 years old * History of adverse reactions within four hours after foods containing wheat or gluten * IgE sensitization to wheat by positive SPT or serum sIgE level * Parent give informed written consent to participate Second stage to commence oral immunotherapy of wheat for 12 months: * Failed wheat double-blind, placebo-controlled food challenge (DBPCFC) under stage I * 3-17 years old * Body weight more than 8 kg * IgE sensitization to wheat by positive SPT or serum sIgE level * Parent give informed written consent to participate Exclusion Criteria: First stage for diagnosis of immediate-type wheat allergy: * Eczema flare or severe allergic reactions within 4 weeks * Intake of antihistamines within 1 week * Systemic corticosteroid treatment within 4 weeks * Intravenous immunoglobulin, systemic immunosuppressive or biologic within 3 months * Inability to follow the requirements and expected procedure of DBPCFC Second stage of wheat oral immunotherapy for 12 months: * History of severe anaphylaxis to wheat * Severe anaphylaxis during double-blind placebo-controlled wheat challenge from stage 1 * Active medical conditions * Use of beta-blockers or angiotensin-converting enzyme inhibitors * Have received other food oral immunotherapy treatment within 12 months * Eczema flare or severe allergic reactions within 4 weeks; * Intake of antihistamines within 1 week * Systemic corticosteroid treatment within 4 weeks; * On Intravenous immunoglobulin, systemic immunosuppressive or biologic within 3 months * Inability to follow the requirements and protocol for wheat oral immunotherapy
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What it tests

  • Wheat-containing food
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Where

1 site
Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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