Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Not Applicable

Recruiting

• Conditions: Immunotherapy; Wheat Hypersensitivity
• Interventions: Other: Wheat (Four times per week)

• Registration Number: NCT06035328
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study First Submitted: 2023-04-18
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2027-03-22
• Study Completion: 2027-03-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four per week	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

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changing in Body weight	13 months	Changing in Body weight in kilograms
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.
Adverse reactions	13 months	Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Specific IgG4 to wheat	13 months	Specific IgG4 to wheat
Specific IgE to wheat	13 months	Specific IgE to wheat
Quality of life by using FAQLQ-PF	13 months	Quality of life before and after enrollment by using FAQLQ-PF

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand