Primary outcome of the PETIT trial. Egg group received 50 mg/day heated egg powder from 6-9 months then 250 mg/day to 12 months. The trial was terminated early at a scheduled interim analysis of 100 participants (egg allergy 4/47 [9%] egg vs 18/47 [38%] placebo; RR 0.222 [0.081-0.607]; p=0.0012); interim stopping typically inflates the point estimate. Largest reported effect size among egg early-introduction trials.
Methodology
Randomised, double-blind, placebo-controlled trial (preregistered UMIN000008673) at two Japanese centres. 121 infants aged 4-5 months with eczema were randomised 1:1 (block size 4, stratified by institution and sex, allocation concealed, participants and physicians masked) to early egg introduction versus placebo. The egg group consumed 50 mg/day heated whole-egg powder from 6-9 months, then 250 mg/day until 12 months; both groups received aggressive eczema treatment maintained without exacerbation throughout. Primary outcome: proportion with hen’s-egg allergy confirmed by standardised, blinded open oral food challenge at 12 months, in all randomised participants who received the intervention. The trial was stopped early at a scheduled interim analysis of 100 participants.
Link to original