Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
研究概览
简要总结
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).
Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.
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
- 1 Day 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects aged between 0-14 years
- •suggestive history of food allergy
排除标准
- •age >14 years-
- •chronic systemic diseases,
- •malignancy,
- •immunodeficiency,
- •infectious diseases,
- •autoimmune diseases,
- •inflammatory bowel diseases,
- •celiac disease,
- •metabolic and genetic diseases,
- •cystic fibrosis,
- •chronic pulmonary diseases,
- •gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
- •neurologic and/or neuropsychiatric disorders,
- •gastrointestinal tract eosinophilic disorders,
- •use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the previous 4 months
研究组 & 干预措施
Non IgE-mediated food allergy
Children with non IgE-mediated food allergy
干预措施: Non IgE-mediated food allergy (Other)
结局指标
主要结局
Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
时间窗: After 72 months from the study start
Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march
Evaluation of clinical features of non-IgE mediated food allergies in children
时间窗: After 72 months from the study start
Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)
次要结局
- Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies(through study completion, an average of 2 years)
- Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children(through study completion, an average of 2 years)
研究者
Roberto Berni Canani, MD, PhD
Professor of Pediatrics
Federico II University