Randomized Controlled Trial for Wheat Oral Immunotherapy
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
| Condition(s) | Allergy;Food, Wheat Allergy, Children |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 I |
| Who can participate | 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 * Sy |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Lead sponsor | Chinese University of Hong Kong |
| Locations | Hong Kong, Hong Kong |
| Start date | 2023-11-01 |
| NCT ID | NCT06069492 |
| Official listing | https://clinicaltrials.gov/study/NCT06069492 |