Tolerability of a new amino acid-based formula for children with IgE-mediated cow’s milk allergy

BACKGROUND: Amino acid-based formula (AAF) is a relevant dietary strategy for paediatric patients affected by cow’s milk allergy (CMA). The present study was designed to evaluate the hypoallergenicity of a new AAF in children with immunoglobulin (Ig)E-mediated CMA. METHODS: According to the criteria provided by the American Academy of Pediatrics Subcommittee on Nutrition and Allergic Diseases, we designed a prospective trial in CMA children (aged 1–36 months) aimed to demonstrate the hypoallergenicity of the new AAF in 90% of subjects with 95% confidence during the double-blind, placebo-controlled challenge (DBPCFC). A skin prick test (SPT) with the new AAF was also performed. RESULTS: Twenty-nine children [all Caucasian, 55.2% male, mean age (±SD) 16.9 ± 5.7 months] were enrolled. The SPT and the DBPCFC with the new AAF were negative in all study subjects. CONCLUSIONS: The study results support the hypoallergenicity of the new AAF. This formula could be considered an additional dietary option for non-breastfed children affected by CMA. TRIAL REGISTRATION: The trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT03909113). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13052-021-01096-3.