Comparing two dosing schedules for wheat allergy treatment
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
This study is testing whether giving children with wheat allergies their treatment once a day or four times a week works better to help them not react to wheat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | Omalizumab, immunotherapy |
| Locations | 1 site (Bangkoknoi, Bangkok) |
| Trial ID | NCT06035328 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years with a history of IgE mediated wheat allergy and a positive oral food challenge test.
Not a fit: Patients with uncontrolled atopic dermatitis, asthma, or other chronic diseases, as well as those on certain medications or with developmental issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and standardized treatment options for children with wheat allergies.
How similar studies have performed: While there is variability in OIT protocols, this specific comparison of dosing schedules is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bangkoknoi, Bangkok
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.