Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Allergy to nuts (cashew, pistachio, walnut, exotic nuts) is a frequent allergy in children, with a prevalence of up to 4.9% of the population and a low resolution rate (9%). Among the nut allergies, cashew nut allergy is one of the most frequent in Northern Europe: in France 41% of children allergic to nuts are sensitized to cashew nuts. Moreover, cashew nut allergy is associated with severe reactions that can be lethal in both adults and children. These reactions may even be more severe than those observed with peanuts, with more frequent respiratory and cardiovascular impairment. We note reactions for even limited contacts (cutaneous or mucous) and low reactogenic thresholds. However, the only recommendation for management at present is avoidance. The stakes of oral immunotherapy protocols cashew would be similar to those for peanut immunotherapy: to limit reactions in case of accidental intake, increase the reactogenic threshold and thus improve the quality of life of allergic patients.
To date, only one study has focused on the efficacy and tolerance of cashew immunotherapy : the prospective NUT CRACKER study conducted on 50 children aged 4 years or older with cashew nut allergy between 2016 and 2019, reports a good efficacy of immunotherapy on increasing threshold for cashew nut but also for pistachio and walnut, when there was a cross-over allergy. While the tolerance was similar to other immunotherapy protocols for the other foods.
The objectives of part 2 of the CAJESITO study are (i) to evaluate the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew immunotherapy and (ii) to identify risk factors for severe risk factors for severe allergic reactions during oral cashew 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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 18 years of age with a known allergy to cashew nuts cashew nut allergy and followed in the pediatric allergology unit of Nancy University Hospital.
- •Patients who have received oral cashew immunotherapy for at least 18 months at 28/02/2023
排除标准
- •Patients who have received oral cashew immunotherapy for less than for less than 18 months.
- •Patients lost to follow-up for more than 3 years (last visit in 2020 or earlier)
结局指标
主要结局
Safety
时间窗: during the dose escalation phase and during 6 months of maintenance
To evaluate the safety of oral cashew immunotherapy during the dose escalation phase and during the maintenance phase : Frequency of occurrence of at least one allergic reaction during the dose escalation phase and during the first 6 months of maintenance
次要结局
- Frequency of allergic reaction(during the dose escalation and maintenance phases : first 6 months, 1st year, 2nd year, 3rd year)
- Describe the severity of allergic reactions(during the dose escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year))
- Predictive factors of severe allergic reactions(during cashew nut immunotherapy)
- Factors associated with severe allergic reactions(during cashew nut immunotherapy)
- Immunotherapy discontinuation(during cashew nut immunotherapy)
研究者
Amandine DIVARET-CHAUVEAU
PhD
Central Hospital, Nancy, France