Efficacy of the Enquiring About Tolerance (EAT) study among infants at high risk of developing food allergy

Abstract

Background: The Enquiring About Tolerance (EAT) study was a randomized trial of the early introduction of allergenic solids into the infant diet from 3 months of age. The intervention effect did not reach statistical significance in the intention-to-treat analysis of the primary outcome.

Objective: We sought to determine whether infants at high risk of developing a food allergy benefited from early introduction.

Methods: A secondary intention-to-treat analysis was performed of 3 groups: nonwhite infants; infants with visible eczema at enrollment, with severity determined by SCORAD; and infants with enrollment food sensitization (specific IgE ≥0.1 kU/L).

Results: Among infants with sensitization to 1 or more foods at enrollment (≥0.1 kU/L), early introduction group (EIG) infants developed significantly less food allergy to 1 or more foods than standard introduction group (SIG) infants (SIG, 34.2%; EIG, 19.2%; P = .03), and among infants with sensitization to egg at enrollment, EIG infants developed less egg allergy (SIG, 48.6%; EIG, 20.0%; P = .01). Similarly, among infants with moderate SCORAD (15-<40) at enrollment, EIG infants developed significantly less food allergy to 1 or more foods (SIG, 46.7%; EIG, 22.6%; P = .048) and less egg allergy (SIG, 43.3%; EIG, 16.1%; P = .02).

Conclusion: Early introduction was effective in preventing the development of food allergy in specific groups of infants at high risk of developing food allergy: those sensitized to egg or to any food at enrollment and those with eczema of increasing severity at enrollment. This efficacy occurred despite low adherence to the early introduction regimen. This has significant implications for the new national infant feeding recommendations that are emerging around the world.

Keywords: Food allergy; adherence; allergens; breastfeeding; diet; infancy; randomized controlled trial.

Graphical abstract

Fig 1

Intention-to-treat efficacy of the EAT study by enrollment eczema SCORAD score group.

Fig 2

Intention-to-treat efficacy of the EAT study by ethnicity.

Fig 3

Intention-to-treat efficacy of the EAT study among infants sensitized (IgE ≥0.1 kU/L) at enrollment.

Fig E1

EAT enrollment and randomization. Baseline visits occurred when participants were 3 months of age. *Eight infants randomized to each group were found to have significant health issues either on blood testing or on clinical examination at the enrollment visit, rendering them ineligible for enrollment: conditions included severe vitamin D deficiency, severe iron deficiency, severe failure to thrive, familial hypercholesterolemia, congenital stridor, epidermolysis bullosa, and cartilage-hair hypoplasia syndrome. †Forty-three participants in the SIG and 69 participants in the EIG withdrew voluntarily from the study. Reasons given were as follows: concerns about blood tests (SIG, 0; EIG, 2), emigration (SIG, 10; EIG, 12), expenses (SIG, 1; EIG, 1), family health issues (SIG, 3; EIG, 0), family issues (SIG, 2; EIG, 4), no reason given (SIG, 11; EIG, 16), lost contact with family (SIG, 15; EIG, 28), too far to travel for study assessments (SIG, 0; EIG, 1), and unhappy participating in the study (SIG, 1; EIG, 5).