Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Mahidol University

Status: Enrolling

Conditions: Immunotherapy; Wheat Hypersensitivity

Treatments: Other: Wheat (Four times per week)

Study type: Interventional

Funder types: Other

Identifiers

NCT06035328

069/2566(IRB3)

Details and patient eligibility

About

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

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Four per week

Experimental group

Description:

Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Treatment:

Other: Wheat (Four times per week)

Once daily

No Intervention group

Description:

Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT