Whole goat milk versus cow milk formula and atopic dermatitis in infants: A randomized clinical trial

Atopic dermatitis (AD) poses a substantial burden on affected children and their families. The evidence of the role of feeding choices in infancy for AD development is limited.

This study is a two-arm, parallel, randomized, double-blind, controlled trial to assess the effect of infant feeding with whole goat milk formula (WGF) versus cow milk formula (CF) on AD development during the first year of life. Healthy term infants up to 3 months of age were enrolled in 6 Spanish and 4 Polish study centres, without AD risk selection. The primary outcome measure was AD diagnosed by study personnel at three study visits using the United Kingdom Working Party diagnostic criteria (AD_Primary). Reported doctor-diagnosed AD (AD_Doctor) was a secondary outcome. Cumulative incidence in the first year of life was calculated. Incidence rate ratios (IRR) were estimated by Poisson regression.

Data from 2132 infants were analyzed. 192 infants were diagnosed with AD_Primary and 245 with AD_Doctor. The cumulative incidence rate of AD_Primary for both groups was 11.6 per 100 person-years without difference between WGF and CF (IRR: 1.00; 95%CI: 0.75, 1.32; p = 0.991). In the per-protocol population, the incidence of AD_Doctor was lower in WGF than CF (IRR: 0.66; 95%CI: 0.49, 0.9; p = 0.008). In infants with parental history of AD, the protective effect of WGF was stronger: AD_Doctor IRR 0.36 (95%CI: 0.17, 0.76; p = 0.007).

This trial demonstrates that WGF can reduce the incidence of AD in formula-fed infants in the first year of life, especially in presence of parental history of AD.

ClinicalTrials.gov Identifier: NCT04599946. Submitted: 2020-10-05.