Children Clinical Trial
— WOIT-RCTOfficial title:
Precision Diagnosis and Tolerance Induction in Children With Immediate-type Wheat Allergy
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 immunotherapy (OIT) for treating these paediatric patients. For the initial part, this study will recruit children with immediate-onset adverse reactions after wheat ingestion for different allergy tests, with their wheat allergy ascertained by the gold-standard double-blind, placebo-controlled food challenge. The investigators will then recruit the wheat-allergic children into a randomized, double-blind, parallel-group clinical trial with low-dose and standard-dose wheat OIT for 12 months. The main outcomes include the diagnostic performance of different conventional and novel allergy tests for challenge-confirmed wheat allergy and the rates of desensitization and sustained unresponsiveness achieved by the two dosing regimens of wheat OIT.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wheat-allergic patients who develop sustained unresponsiveness to wheat after oral immunotherapy | The occurrence of sustained unresponsiveness to wheat is detected at 1 month after discontinuation of oral immunotherapy by double-blind, placebo-controlled wheat challenge | 13 months | |
Secondary | Wheat-allergic patients who develop desensitization to wheat after oral immunotherapy | The occurrence of desensitization to wheat is detected at the end of 12-month oral immunotherapy by double-blind, placebo-controlled wheat challenge | 12 months | |
Secondary | Correlation among skin prick test (SPT), specific IgE level (sIgE) and basophil activation test (BAT) with crude wheat extract and wheat allergens and their diagnostic accuracy for wheat allergy | Skin Prick Test, specific IgE and BAT with crude wheat extract and wheat allergens and their diagnostic accuracy for wheat allergy are correlated | 3 years | |
Secondary | Stepwise diagnostic algorithms of different biomarkers for wheat allergy | Outcome provides a stepwise diagnostic algorithms of different biomarkers for wheat allergy | 3 years | |
Secondary | Changes in different allergy biomarkers after low-dose oral immunotherapy and standard-dose oral immunotherapy for wheat | Changes in different allergy biomarkers that is skin prick test, specific IgE after low-dose and standard-dose OIT | 18 months | |
Secondary | Treatment compliance to wheat oral immunotherapy intervention | Compliance to OIT intervention by diary record and the numbers of consuming products | 12 months | |
Secondary | Tolerability and safety between standard-dose and low-dose arms of wheat oral immunotherapy | Assess the tolerability and safety between two oral immunotherapy arms by recording any adverse reactions or severe adverse reactions during the intervention period. | 12 months |
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