Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Study Overview
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Brief Summary
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Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT

Detailed Description
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All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT. The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life

Official Title
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Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy

Conditions
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Wheat Hypersensitivity, Immunotherapy

Intervention / Treatment
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* Other: Wheat (Four times per week)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5-18 years old Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT Exclusion Criteria: Patient with low dose OIT protocol Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease; Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab) Patients with a developmental problem or mental disorder Active eosinophilic gastrointestinal disease in the past 2 years Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers Pregnancy or lactation Patient who could not visit clinic as protocol

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Four per week<br>Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT | Other: Wheat (Four times per week)<br>* Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT<br>|
| No Intervention: Once daily<br>Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term unresponsiveness rate | Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT. Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific IgE to wheat | Specific IgE to wheat | 13 months | 
| Specific IgG4 to wheat | Specific IgG4 to wheat | 13 months | 
| Changing in Body weight | Changing in Body weight in kilograms | 13 months | 
| Compliance | Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption. | 12 months | 
| Adverse reactions | Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system | 13 months | 
| Quality of life by using FAQLQ-PF | Quality of life before and after enrollment by using FAQLQ-PF | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness