Oral Immunotherapy With Egg
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Percentage of children who develops tolerance to egg per year
研究概览
简要总结
In children allergic to egg, oral immunotherapy (OIT) with egg may accelerate that the children grow out of the food allergy.
Children than have a positive oral food provocation with egg with a low threshold, will be offered to start OIT. This means that the child have to ingest a small amount of egg every day.
Once a year, the child will undergo a new oral food provocation to investigate if the child is still allergic to egg or not.
The age of the children at time of this acquired tolerance will be compared with a historical cohort of children with egg allergy.
详细描述
The aim of the study is to investigate if OIT with egg white can accelerate tolerance to egg in infants with provocation-verified allergy to egg and with a low threshold.
The study is non-randomised. Children fulfilling the inclusion criteria will be offered OIT. The children will undergo an oral provocation once a year to detect development of tolerance to egg. Age at tolerance acquisition will be compared with a histical cohort of aged-matched children with allergy to egg and with a similar threshold at the diagnostic provocation
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive specific IgE to egg
- •positive oral provocation for egg
- •low threshold
排除标准
- •uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines
研究组 & 干预措施
OIT egg
children with allergy to egg diagnosed after January 2026 will be offered OIT
干预措施: low-dose OIT egg (Other)
Non-OIT
Aged-matched children with allergy to egg diagnosed before January1, 2026, not offered OIT
结局指标
主要结局
Percentage of children who develops tolerance to egg per year
时间窗: If the oral food provocation is negative (that is the child is still allergic to egg) the child will be re-provocated after 12 months. As long as the provocation is positive it will be repeated once a year for 5 years
Once a year the children will undergo an oral food provocation with egg to investigate if they have becomed tolerant to egg
次要结局
- specific IgE(baseline and through study completion, an average of 1 year)
研究者
Josefine Gradman
MD, PhD
Odense University Hospital