Immunotherapy Clinical Trial
Official title:
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
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
Status | Recruiting |
Enrollment | 64 |
Est. completion date | March 22, 2027 |
Est. primary completion date | March 22, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short term unresponsiveness rate | 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 |
13 months | |
Secondary | Specific IgE to wheat | Specific IgE to wheat | 13 months | |
Secondary | Specific IgG4 to wheat | Specific IgG4 to wheat | 13 months | |
Secondary | Changing in Body weight | Changing in Body weight in kilograms | 13 months | |
Secondary | Compliance | 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. | 12 months | |
Secondary | Adverse reactions | Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system | 13 months | |
Secondary | Quality of life by using FAQLQ-PF | Quality of life before and after enrollment by using FAQLQ-PF | 13 months |
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