Du Toit · The New England journal of medicine 2015 · Randomized controlled trial · n=640

Randomized trial of peanut consumption in infants at risk for peanut allergy.

Level 2 - randomized trial

Individual randomized controlled trial

PubMed 25705822 · doi:10.1056/NEJMoa1414850 · record verified 2026-08-26

What was done

A randomized controlled trial evaluated peanut consumption versus avoidance in 640 infants (aged 4 to <11 months) at high risk for peanut allergy due to severe eczema, egg allergy, or both. Participants were stratified by baseline peanut skin-prick test into a negative wheal cohort and a 1–4 mm wheal cohort, then assigned to either consume or avoid peanut products until 60 months of age. The primary outcome was peanut allergy prevalence at 60 months assessed independently in each cohort.

What was found

Among infants with negative baseline skin-prick tests (n = 530, intention-to-treat), peanut allergy at 60 months was 13.7% in the avoidance group versus 1.9% in the consumption group (P < 0.001). Among infants with positive baseline tests (n = 98, intention-to-treat), allergy prevalence was 35.3% in the avoidance group versus 10.6% in the consumption group (P = 0.004). Serious adverse event incidence did not differ significantly between groups. Peanut-specific IgG4 increased predominantly in the consumption group, whereas elevated peanut-specific IgE titers were more common with avoidance.

Why it matters

Early dietary introduction of peanuts substantially reduces the risk of developing peanut allergy in high-risk infants, challenging long-standing recommendations for delayed allergen introduction.

Limits

The study was restricted to infants aged 4–11 months with severe eczema, egg allergy, or both, and did not include infants with large baseline skin-prick wheals (>4 mm). Findings cannot be directly extrapolated to general low-risk infant populations, and persistence of tolerance after cessation of consumption was not reported here.