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临床试验/JPRN-UMIN000008673
JPRN-UMIN000008673已完成3 期

Prevention of egg allergy in infants with atopic dermatitis. - Prevention of egg allergy with tiny amount intake.

ational Center for Child Health and Development0 个研究点目标入组 200 人开始时间: 2012年8月10日最近更新:
适应症

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.

研究者

发起方
ational Center for Child Health and Development

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