Status:
RECRUITING
Randomized Controlled Trial for Wheat Oral Immunotherapy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Allergy;Food
Wheat Allergy
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief 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 me...
Detailed Description
Study Background Wheat (Triticum aestivum) is one of the foods with wide global consumption and one of the Big 8 foods causing allergy. IgE-mediated wheat allergy tends to be associated with severe a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06069492
Start Date
November 1 2023
End Date
August 31 2027
Last Update
February 8 2024
Active Locations (1)
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1
Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital
Hong Kong, Hong Kong, 0000