Comparing two dosing schedules for wheat allergy treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of two different maintenance dosing schedules for oral immunotherapy (OIT) in children with IgE mediated wheat allergy. Participants will receive either a once daily dose or a four times per week dose of wheat OIT over a one-year maintenance phase. The primary goal is to compare the short-term unresponsiveness rates between the two dosing regimens, while also monitoring various immunologic parameters, body weight changes, compliance, adverse reactions, and quality of life. This research aims to standardize OIT protocols and improve treatment outcomes for wheat allergy patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Siriraj Hospital
  Bangkoknoi, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Punchama Pacharn, MD — Mahidol University, Siriraj Hospital,Thailand
• Study coordinator: Punchama Pacharn, MD
• Email: punchama@gmail.com
• Phone: 024197000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.