Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Short term unresponsiveness rate
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Short term unresponsiveness rate
时间窗: 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
次要结局
- Changing in Body weight(13 months)
- Compliance(12 months)
- Adverse reactions(13 months)
- Specific IgG4 to wheat(13 months)
- Specific IgE to wheat(13 months)
- Quality of life by using FAQLQ-PF(13 months)