Clinical trial NCT06035328: Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
Official title: Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wheat Hypersensitivity
Immunotherapy
Keywords: Wheat Hypersensitivity
Immunotherapy
Short term unresponsiveness
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Short term unresponsiveness rate
timeFrame: 13 months
Secondary outcomes:
measure: Specific IgE to wheat
timeFrame: 13 months
measure: Specific IgG4 to wheat
timeFrame: 13 months
measure: Changing in Body weight
timeFrame: 13 months
measure: Compliance
timeFrame: 12 months
measure: Adverse reactions
timeFrame: 13 months
measure: Quality of life by using FAQLQ-PF
timeFrame: 13 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University, Siriraj Hospital,Thailand
name: Punchama Pacharn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.