Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT06069492
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT06069492
Study Brief:
Protocol Section:
NCT06069492