Efficacy of Cashew Nut Protein Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Cashew full tolerance
研究概览
简要总结
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.
详细描述
According to Polish data, in the population of children suspected of food allergy, cashew was the third nut found to be allergic, after peanut and hazelnut. Allergic reactions to nuts can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.
An effective and safe alternative to allergen avoidance strategies may be the use of oral specific immunotherapy.
In this study 39 children, aged 4 to 17 years with a diagnosis of IgE-dependent allergy to cashew, confirmed by an open oral provocation test (OFC; the first provocation before starting oral desensitization), will be randomly (2:1) assigned to two groups. The first group will be desensitized with a maintenance dose - 1200mg of cashew protein, while the second group - the control group - will be offered standard management - avoidance of cashew consumption.
Patients in the control group will be offered immunotherapy at the end of the study if its effectiveness is confirmed.
The desensitization procedure was planned in accordance with the guidelines for immunotherapy in food allergy of the European Academy of Allergology and Clinical Immunology.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 4 and 17 years,
- •IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA/l),
- •allergic reaction to cashew protein during oral food challenge (OFC),
- •Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
- •Patient's and caregivers' cooperation with the researcher.
排除标准
- •no confirmed allergy to cashew,
- •negative provocation test with cashew,
- •severe asthma,
- •mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) <80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) <75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,
- •oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
- •eosinophilic gastroenteritis,
- •chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- •taking medications:
- •oral, daily steroid therapy >1 month in the past 12 months,
- •a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,
- •one-time oral steroid therapy (min. 7 days) in the last 3 months,
- •biological treatment,
- •need to take antihistamines continuously,
- •therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,
- •pregnancy,
- •lack of consent to participate in the study,
- •lack of patient cooperation.
结局指标
主要结局
Cashew full tolerance
时间窗: Up to 60 weeks of OIT (oral immunotherapy)
Percentage of children tolerating a single dose of 4g of cashew protein after 12 weeks of immunotherapy at a maintenance dose.
次要结局
- Basophil activation test (BAT)(Up to 60 weeks of OIT (oral immunotherapy))
- Cashew partial tolerance(Up to 60 weeks of OIT (oral immunotherapy))
- OIT safety(Up to 60 weeks of OIT (oral immunotherapy))
- IgG4 (immunoglobulin IgG4) (mgA/l) levels(Up to 60 weeks of OIT (oral immunotherapy))
- Wheal diameter in skin prick tests(Up to 60 weeks of OIT (oral immunotherapy))
- SIgE (specific immunoglobulin E) (kUA/l) levels(Up to 60 weeks of OIT (oral immunotherapy))
- Quality of life- FAQLQ (Food Allergy Quality of Life Questionnaire)(Up to 60 weeks of OIT (oral immunotherapy))
- Air condensate(Up to 60 weeks of OIT (oral immunotherapy))