Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form : a Multicentre Prospective Study - National FPIES Observatory
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- tolerance acquisition
研究概览
简要总结
Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and during evolution during three years
详细描述
Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel.
The offending food depend on the country, probably in relation to eating habits.
Cow's milk (CM) is most commonly incriminated and can lead to a chronic digestive disease or in its acute form with potentially life-threatening vomiting/diarrhoea/dehydration, confusing with anaphylaxis. Rice and oat in US, or fish and egg in France are the solid food most often implicated.
This disease is usually unknown by clinicians. Its diagnostic is based on clinical history, and differential diagnosis elimination.
In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis and management. According to this last definition (JACI 2017), patient have to meet the major criterion and at least 3 minor criteria. Major criterion is vomiting in the 1- to 4-h period after ingestion of the suspect food and absence of classic IgE-mediated allergic skin or respiratory symptoms. Minor criteria are :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 0 to 17 years old,
- •seen in allergologist visit for acute FPIES, due to history of suggestive clinical symptoms, confirmed by the criteria published in 2017 in the JACI (Nowak-Wegrzyn et al, JACI 2017), or by an oral food challenge for diagnosis in the absence of the requested clinical criteria,
- •affiliated to social security (public healthcare system)
- •signed consent of one of the parents or the holder of parental authority
排除标准
- •Associated pathology that may contraindicate OFC at the discretion of the investigating physician. In particular justifying permanent treatment with a beta-blocker or an angiotensin-converting enzyme inhibitor.
结局指标
主要结局
tolerance acquisition
时间窗: through study completion, an average of 6 years
The acquisition of tolerance will be defined by negative OFC or accidental intake of the food at home tolerated according to parents discussion
次要结局
- IgE-mediated allergy(at 1 year, 2 years, 3 years post inclusion)
- population description(through study completion, an average of 6 years)
- multiple FPIES(at 1 year, 2 years, 3 years post inclusion)
- Atopic comorbidities(at 1 year, 2 years, 3 years post inclusion)
- IgE-dependent allergy(at 1 year, 2 years, 3 years post inclusion)
- IgE sensitization(at 1 year, 2 years, 3 years post inclusion)
- food sensitization(at 1 year, 2 years, 3 years post inclusion)