Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy.
研究概览
简要总结
Prospective, monocentric, observational study with standard care follow-up during 5 years or until the patient reaches the age of 18.
The aim of this study is to prospectively and comprehensively assess the characteristics of patients aged 6 months to 17 years with leguminous allergy (excluding peanut) and their reactions to leguminous, including both medical history and prospective follow-up for 5 years from inclusion, or until the age of 18. The study aims to improve the understanding of these allergies, provide epidemiological data, and optimize diagnostic and clinical management. A biobank will also be established, with plasma (one whole blood sample collected at the inclusion) in order to validate future diagnostic tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 6 months to 17 years old
- •Medical diagnosis of allergy to one or more leguminous :
- •Clinical reaction following real-life exposure AND positive skin and/or biological sensitization
- •Allergy confirmed by a positive oral food challenge (OFC) in cases of sensitization without a history of clinical reaction
- •Subjects seen in a pediatric pneumo-allergy unit (consultation or hospitalization)
排除标准
- •Isolated IgE-mediated peanut allergy
- •Patients aged 18 years or older
- •Minor patient or legal representant (parental authority) Refusal
结局指标
主要结局
Prospectively study, among the leguminous, the type of leguminous (excluding peanut) responsible for the allergy.
时间窗: Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18
The primary endpoint will be the number of allergy diagnoses for each type of leguminous (excluding peanut), among : * Green peas * Split peas (dried green peas) * Yellow or blond dried peas * Chickpeas * Green, red, or blond lentils * Green, Kidney, White or Mung beans * Soybean * Lupin * Fenugreek * Fava bean (broad bean) * Beluga lentils * Black-eyed peas (cowpeas), adzuki beans,and urad beans * Alfalfa
次要结局
- Describe quality of life (FAQLQ questionnaires) in children aged 8 years or older(Baseline (Inclusion))
- Describe the age at onset and severity of the first manifestation(Baseline (Inclusion))
- Establish a biobank (blood - plasma samples) to validate future diagnostic tests(Baseline (Inclusion))
- Describe the severity of reactions by legume (FASS score)(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe the frequency of anaphylaxis by legume (according to the WAO definition)(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe the frequency of severe anaphylaxis by legume (FASS-5 Grades 4 and 5)(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe associations between allergies to different leguminous.(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe allergic comorbidities (asthma, rhinitis, atopic dermatitis, and pollinosis)(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe associated food allergies, including peanut and other foods(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Describe allergy management strategies: targeted avoidance, broad avoidance, emergency kit with an adrenaline auto-injector, and school-based management (Individualized Healthcare Plan)(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Assess parents' knowledge of the different leguminous(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)
- Prospectively assess allergic reactions in real-life settings: number of reactions, severity, type of food (prepackaged ready-made meal or homemade meal), labeling, quantity consumed, location of occurrence, and management(Baseline (Inclusion) 1 Year from the Inclusion 5 years from the inclusion, or until the age of 18)