Wheat oral immunotherapy for children with wheat allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.