Randomized Controlled Trial for Wheat Oral Immunotherapy (WOIT-RCT)
Allergy;Food, Wheat Allergy, Children
About this trial
This is an interventional treatment trial for Allergy;Food focused on measuring food allergy, wheat, oral immunotherapy
Eligibility 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
Sites / Locations
- Department of Pediatrics, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard-dose group
Low-dose group
Consumes one serving containing 38 grams wheat pasta daily for 6 days every week
Consumes one serving containing 5 grams wheat pasta and 33 grams gluten-free pasta daily for 6 days every week