Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wheat (Four times per week).
- Who it may be relevant to
- Registry conditions: Wheat Hypersensitivity, Immunotherapy. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
Overview
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
- Other Wheat (Four times per week)
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Primary outcome measures
- Short term unresponsiveness rate [Time frame: 13 months]
Secondary outcome measures (6)
- Specific IgE to wheat [Time frame: 13 months]
- Specific IgG4 to wheat [Time frame: 13 months]
- Changing in Body weight [Time frame: 13 months]
- Compliance [Time frame: 12 months]
- Adverse reactions [Time frame: 13 months]
- Quality of life by using FAQLQ-PF [Time frame: 13 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Siriraj Hospital — Bangkoknoi
Publications
- 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; EAAC PMID 29205393
Identifiers
NCT: NCT06035328 · 069/2566(IRB3)