Randomized Trial of Early Infant Formula Introduction to Prevent Cow’s Milk Allergy

Abstract

To determine if the early introduction of cow’s milk formula (CMF) could prevent the development of cow’s milk allergy (CMA) in healthy infants.In the study, the researchers enrolled 491 newborns within 5 days of birth from 4 hospitals in Okinawa, Japan. Inclusion criteria were a gestational age of at least 35 weeks, a birth weight of at least 2000 g, and the absence of severe underlying disease.Participants were allowed to supplement with CMF before 1 month of age and underwent a screening oral food challenge (OFC) at that time. Those with a negative OFC result were randomly assigned to either the open-label CMF ingestion or avoidance. Those in the CMF ingestion group ingested at least 10 mL of CMF daily between 1 and 2 months of age, whereas those in the avoidance group were instructed to supplement with soy formula if needed during this time. At 3 months of age, an open OFC was performed on all participants. Those who were negative from both groups spontaneously ingested CMF to supplement breastfeeding until 6 months of age, at which time a second open OFC was performed on all participants.The modified intention-to-treat analysis revealed a significantly lower rate of CMA in the ingestion group versus the avoidance group at 6 months of age (0.8% vs 6.8%; respectively; P < .001). Approximately 70% were still breastfed, and no mothers had eliminated cow’s milk. There were no differences in the rate of eczema or sensitization to egg, wheat, or soy between groups.Daily ingestion of at least 10 mL of CMF between 1 and 2 months of life decreased the rate of OFC-confirmed CMA in infants. The early introduction of CMF did not impede breastfeeding.Data supporting the benefit of early introduction of allergenic foods in preventing allergy are accumulating. In this study, researchers examined the impact of introducing a specific daily minimum quantity of CMF in the general infant population, with favorable results. In further studies, researchers could provide interventions in a blinded manner and/or examine the impact of CMF introduction in infants at high-risk of allergy.