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Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Recruiting
5-18 years
All
Phase N/A

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Overview

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

Description

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

Eligibility

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

Study details
    Wheat Hypersensitivity
    Immunotherapy

NCT06035328

Mahidol University

26 January 2024

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