An interventional study of Wheat (Four times per week) in Wheat Hypersensitivity and Immunotherapy, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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
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
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 64 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criteria:
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Other: Wheat (Four times per week)
Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
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
Time frame: 13 months
Specific IgE to wheat
Specific IgE to wheat
Time frame: 13 months
Specific IgG4 to wheat
Specific IgG4 to wheat
Time frame: 13 months
Changing in Body weight
Changing in Body weight in kilograms
Time frame: 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.
Time frame: 12 months
Adverse reactions
Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Time frame: 13 months
Quality of life by using FAQLQ-PF
Quality of life before and after enrollment by using FAQLQ-PF
Time frame: 13 months
Plan to share: No
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Mahidol University