Status:
RECRUITING
Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
Lead Sponsor:
Mahidol University
Conditions:
Wheat Hypersensitivity
Immunotherapy
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 sho...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 22 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06035328
Start Date
July 1 2023
End Date
March 22 2027
Last Update
May 9 2025
Active Locations (1)
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1
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700