Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06035328

Collaborator

(none)

Enrollment

Location

Arms

44.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wheat Hypersensitivity Immunotherapy	Other: Wheat (Four times per week)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 22, 2027

Anticipated Study Completion Date :

Mar 22, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Four per week Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT	Other: Wheat (Four times per week) Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
No Intervention: Once daily Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT

Arm

Intervention/Treatment

Experimental: Four per week

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

Other: Wheat (Four times per week)

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

No Intervention: Once daily

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

Outcome Measures

Primary Outcome Measures

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

Specific IgE to wheat [13 months]
Specific IgE to wheat
Specific IgG4 to wheat [13 months]
Specific IgG4 to wheat
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
Quality of life by using FAQLQ-PF [13 months]
Quality of life before and after enrollment by using FAQLQ-PF

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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