NCT05698030已完成不适用
Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Absence of moderate to severe allergic reactions
研究概览
简要总结
The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
- •Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022
排除标准
- •Patients who have received oral immunotherapy to pistachio for less than 18 months.
- •Patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier
结局指标
主要结局
Absence of moderate to severe allergic reactions
时间窗: during the 6 months of maintenance
with daily intake of 2g of pistachio
次要结局
- Frequency and severity of allergic reactions(during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year))
- Decrease in specific IgE and increase of IGg4 to pistachio(during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year))
- Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio(3 months after stopping daily consumption of 2g pistachio)
- Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut(3 months after stopping daily consumption of 2g pistachio)
- Reactogenic or tolerogenic threshold of cashew nuts(during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year))
研究者
Amandine DIVARET-CHAUVEAU
MCU-PH
Central Hospital, Nancy, France
研究点 (1)
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