Wheat oral immunotherapy for children with wheat allergy
Precision Diagnosis and Tolerance Induction in Children With Immediate-type Wheat Allergy
This study is testing if giving different doses of wheat oral immunotherapy can help children with wheat allergies feel better and manage their reactions over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06069492 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of different dosages of wheat oral immunotherapy (OIT) in children diagnosed with IgE-mediated wheat allergy. It aims to improve diagnostic methods for wheat allergy, which currently rely on inaccurate tests, and to provide a more proactive treatment approach rather than a passive 'wait-and-see' strategy. The study will involve children aged 1-17 who have experienced allergic reactions to wheat and will assess their responses to OIT over a 12-month period. The research is conducted at the Chinese University of Hong Kong, focusing on both the diagnosis and treatment of wheat allergies in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-17 who have a history of adverse reactions to wheat and demonstrate IgE sensitization.
Not a fit: Patients with recent severe allergic reactions or those currently on antihistamines or corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for children suffering from wheat allergies, potentially reducing the risk of severe allergic reactions.
How similar studies have performed: Other studies have shown promise with oral immunotherapy for food allergies, suggesting that this approach may be effective, although specific research on wheat allergy is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Ting Fan Leung, MBChB, MD — Chinese University of Hong Kong
- Study coordinator: Ting Fan Leung, MBChB, MD
- Email: tfleung@cuhk.edu.hk
- Phone: 85235052981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.