Cow’s milk protein allergy (CMPA) is a common condition in the pediatric population, requiring alternative dietary approaches to alleviate allergic symptoms. This study evaluates the efficacy of an amino acid formula as an alternative replacement for cow’s milk in children with CMPA. The hypoallergenic properties of Neocate® is being thoroughly evaluated through extensive preclinical studies and clinical trials in infants and children with documented severe cow’s milk allergy. The research uses rigorous elimination challenge tests, supported by statistical rigor, to establish the formula’s ability to reduce allergic reactions. In addition, the study extends its investigation to children with documented allergies to the protein source of the amino acid formula. To ensure a comprehensive assessment, post-double-blind challenges with objective scoring systems will be used to detect potential delayed allergic reactions. The results highlight the promise of amino acid formula as an effective substitute for cow’s milk in children with severe CMPA, helping to alleviate allergic symptoms and improve the management of this condition. © 2024, Central Medical Library Medical University – Sofia. All rights reserved.