Randomized Controlled Trial for Wheat Oral Immunotherapy

Launched by CHINESE UNIVERSITY OF HONG KONG · Oct 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called wheat oral immunotherapy (OIT) for children who have a wheat allergy. Wheat allergy can cause serious allergic reactions, and this study aims to find safer and more effective ways to diagnose and treat it. The trial will first test children for their wheat allergy using standard allergy tests and a special food challenge, where they will consume wheat in a controlled setting to see if they react. After confirming the allergy, eligible children aged 3 to 17 years who weigh more than 8 kg will participate in a 12-month treatment phase. They will receive either a low or standard dose of wheat OIT to see how well it works in helping them tolerate wheat.

To be eligible for this trial, children must have a history of allergic reactions to wheat within four hours of eating it, and their allergy must be confirmed by allergy tests. Parents will need to provide consent for their child to participate. Throughout the study, participants will be monitored closely for any reactions and to assess how well the treatment is working. It’s important for families to know that this study is looking for a better way to manage wheat allergies, which can significantly impact daily life for affected children.

Gender

ALL

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