RecruitingNot ApplicableNCT06035328

Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

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


Sponsor

Mahidol University

Enrollment

64 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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Interventions

OTHERWheat (Four times per week)

Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT


Locations(1)

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

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NCT06035328


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