Randomized Controlled Trial for Wheat Oral Immunotherapy

Recruiting now · Not applicable

Conditions studied: Allergy;Food, Wheat Allergy, Children

In brief

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.

Key facts

Study ID: NCT06069492
Run by: Chinese University of Hong Kong
People needed: 72
Starts: 2023-11-01
Expected to finish: 2027-08-31
Last updated by the study team: 2024-02-08

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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