Immunotherapy, Wheat Hypersensitivity
Conditions
Keywords
Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness
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 short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT
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 outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life
Interventions
OTHERWheat (Four times per week)
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term unresponsiveness rate | 13 months | Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT. Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific IgG4 to wheat | 13 months | Specific IgG4 to wheat |
| Changing in Body weight | 13 months | Changing in Body weight in kilograms |
| Specific IgE to wheat | 13 months | Specific IgE to wheat |
| Adverse reactions | 13 months | Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system |
| Quality of life by using FAQLQ-PF | 13 months | Quality of life before and after enrollment by using FAQLQ-PF |
| Compliance | 12 months | Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption. |
Countries
Thailand
Contacts
Primary ContactPunchama Pacharn, MD
Outcome results
None listed