Prevention of egg allergy in infants with atopic dermatitis. - Prevention of egg allergy with tiny amount intake.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
ancet. 2017 Jan 21;389(10066):276-286. doi: 10.1016/S0140-6736(16)31418-0. Between Sept 18, 2012, and Feb 13, 2015, we randomly allocated 147 participants (73 [50%] to the egg group and 74 [50%] to the placebo group). This trial was terminated on the basis of the results of the scheduled interim analysis of 100 participants, which showed a significant difference between the two groups (four [9%] of 47 participants had an egg allergy in the egg group vs 18 [38%] of 47 in the placebo group; risk ratio 0.222 [95% CI 0.081-0.607]; p=0.0012). In the primary analysis population, five (8%) of 60 participants had an egg allergy in the egg group compared with 23 (38%) of 61 in the placebo group (risk ratio 0.221 [0.090-0.543]; p=0.0001). The only difference in adverse events between groups was admissions to hospital (six [10%] of 60 in the egg group vs none in the placebo group; p=0.022). 19 acute events occurred in nine (15%) participants in the egg group versus 14 events in 11 (18%) participants in the placebo group after intake of the trial powder. conclusion Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent egg allergy in high-risk infants. In this study, we developed a practical approach to overcome the second wave of the allergic epidemic caused by food allergy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 4months-old 至 6months-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Infants born before 37 weeks of gestation. (2) Infants who have already being fed with egg. (3) Infants with a history of immediate type allergic reaction to egg. (4) Infants with possible atypical food allergy other than immediate type food allergy. (5) Infants with severe complications.
