Prevention of egg allergy in infants with atopic dermatitis.

Phase 3

• Conditions: food allergy

• Registration Number: JPRN-UMIN000008673
• Lead Sponsor: ational Center for Child Health and Development

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-10
• Study Completion: 2015-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified