Paediatric Observatory of Oral Food Tolerance Induction in the Allergy Department of the Saint-Vincent de Paul Hospital in Lille
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Age
研究概览
简要总结
The goal of this study is to set up a paediatric observatory within the allergology department of The saint Vincent Hospital, Lille. The study aims to:
• Collect exhaustive prospective data from patients eligible for oral immunotherapy.
This prospective observatory will enable statistical analyses to be carried out on common food allergens such as hazelnut, cashew nut, pistachio and others.
详细描述
During the consultation, the allergist will inform the legal representative and the child about the terms of the study, and will provide them with an information note specifying the objectives of the study and its terms, the involvement of the child and his or her rights.
Depending on the allergen involved, the oral immunotherapy session will be assigned to one of three study groups: 1) allergen to hazelnut, walnut, pistachio, cashew or peanut,2) allergen to cow's milk, wheat or egg, 3) allergen to unusual foods: sesame, celery, fenugreek, peas, lentils, etc.
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Oral immunotherapy will then be started in accordance with standard practice. During this first visit, the investigator will give the patient a diary in which to record information about any IgE-mediated side-effects of the oral immunotherapy. Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol. Visits will be made every 6 months, with a window of two months around each date.During these monitoring visits, tthe collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be continue.
During each visit, a new food challenge test may be performed at the investigator's discretion to assess a new reactogenic threshold. Following this test, the following data will be collected:
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Age
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Sex
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Oral immunotherapies followed before inclusion
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Determination of comorbidities
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Determination of allergen under consideration
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Specific IgE
时间窗: at inclusion
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Recombinants
时间窗: 5 years
For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done
Cumulative ingested dose
时间窗: 5 years
This dose will be determined by mg/food and m/ food protein
Allergic reaction according to the Astier and Coll classification
时间窗: 5 years
Astier score for anaphylaxis according to symptoms: 0- Absent 1- Abdominal pain spontaneous resolution, Urticaria \< 10 papules, Eczema, Rhinoconjunctivitis 2-1 Organ affected, Abdominal pain requiring treatment, Angioedema with laryngeal involvement, Moderate asthma: cough and PEF \> 20%. 3- 2 Affected organs 4- 3 organs affected or Asthma attack requiring treatment or Laryngeal edema or Arterial hypotension 5- Cardiorespiratory impairment requiring ICU admission
Type of oral challenge
时间窗: 5 years
Type of ingested food during the oral immunotherapy: fresh food / industrial products
Reception of emergency kit
时间窗: 5 years
If the reception of an emergency kit was needed will be determined by yes/no
Second oral food challenge
时间窗: 5 years
If a second oral challenge was needed will be determined by yes/no
Tolerance according to reactogenic thresholds for allergens
时间窗: 5 years
Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.
Amount of reactions IgE mediated
时间窗: 5 years
Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.
Amount of reactions non IgE mediated
时间窗: 5 years
Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.
次要结局
未报告次要终点