Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
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 whea
| Condition(s) | Wheat Hypersensitivity, Immunotherapy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Lead sponsor | Mahidol University |
| Locations | Bangkoknoi, Bangkok, Thailand |
| Start date | 2023-07-01 |
| NCT ID | NCT06035328 |
| Official listing | https://clinicaltrials.gov/study/NCT06035328 |