Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Recruiting now · Not applicable

Conditions studied: Wheat Hypersensitivity, Immunotherapy

In brief

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

Key facts

Study ID

NCT06035328

Run by

Mahidol University

People needed

64

Starts

2023-07-01

Expected to finish

2027-03-22

Last updated by the study team

2025-05-09

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Siriraj Hospital — Bangkoknoi, Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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