Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Mahidol University64 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wheat Hypersensitivity Immunotherapy

Interventions

Wheat (Four times per week)OTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Short term unresponsiveness rate

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

Time frame: 13 months

Secondary Outcomes

Specific IgE to wheat

Time frame: 13 months

Specific IgG4 to wheat

Time frame: 13 months

Changing in Body weight

Changing in Body weight in kilograms

Time frame: 13 months

Compliance

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.

Time frame: 12 months

Adverse reactions

Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system

Time frame: 13 months

Quality of life by using FAQLQ-PF

Quality of life before and after enrollment by using FAQLQ-PF

Time frame: 13 months

Central Contacts

Punchama Pacharn, MD

CONTACT

024197000 punchama@gmail.com

Data from ClinicalTrials.gov

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