Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA
研究概览
简要总结
Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.
The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants under 4 months age with delayed symptoms evoking CMPA
排除标准
- •exclusively breastfed infants
- •no improvement of symptoms despite amino acid formula
- •patients with symptoms of food protein induced enterocolitis
- •patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
结局指标
主要结局
prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA
时间窗: 2 to 8 weeks after inclusion
We proceed to an elimination-reintroduction test of the culprit food (CMP) in patients with delayed symptoms of non IgE-mediated CMPA (rectal bleeding, atopic dermatitis, reflux, excessive crying, failure to thrive...) after a period of two to eight weeks of exclusion of CMP. If symptoms disappear after CMP elimination, and reappear after CMP reintroduction, the diagnosis of CMPA is confirmed.
次要结局
- age of tolerance of confirmed non IgE-mediated CMPA(after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance)
研究者
Anaïs Lemoine
Dr, MD
Hôpital Armand Trousseau