NCT06035328

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Wheat Hypersensitivity
• Immunotherapy

Interventions

Type	Name	Description
OTHER	Wheat (Four times per week)	Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Timeline

• Start date: 2023-07-01
• Primary completion: 2027-03-22
• Completion: 2027-03-22
• First posted: 2023-09-13
• Last updated: 2025-05-09

Locations

1 site across 1 country: Thailand