Efficacy and safety of amino acid-based formulas in the management of infants with cow’s milk protein allergy: an open-label prospective controlled study

Aim. To determine the efficacy and safety of long-term use of an amino acid-based formula in children with cow›s milk protein allergy (CMPA) and moderate to severe atopic dermatitis (AD).
Materials and methods. The study included 60 children under 12 months of age with CMPA presenting with cutaneous symptoms (moderate or severe AD according to the oSCORAD) and/or gastrointestinal symptoms. Prior to the study, all patients were prescribed an extensively hydrolyzed formula (EHF) for 4 weeks. Patients with no or incomplete response to EHF (n = 30) were assigned to Group 1, receiving an amino acid-based formula (AAF) for 12 months. The 30 patients who showed a positive response to EHF were assigned to Group 2.
Results. Children in Group 1 showed greater gains in weight and height during the first 6 months compared to children in Group 2 (p < 0.001). The resolution of gastrointestinal symptoms in children receiving AAF was observed within 14 days along with an improvement in the clinical picture of AD within 3–5 days. Also, both groups showed a decrease in oSCORAD and EASI scores; however, children receiving AAF had a significantly smaller number of exacerbations (p = 0.041) and a lower impact of dermatosis on daily activities (p = 0.002). After 6 months of therapy, 53.3% of children in Group 1 developed tolerance to cow’s milk proteins, compared to only 23.3% in Group 2 (p = 0.017). After 2 years of follow-up, tolerance was noted in all children who received AAF versus 87.7% of those fed with EHF.
Conclusion. The use of AAF in children with CMPA is an effective dietary management method that leads to faster resolution of gastrointestinal symptoms, improvement in the course of atopic dermatitis, and prolongation of its remission. It shortens the period for tolerance development, has a positive effect on the child›s physical development, and contributes to a significant improvement in the quality of life of both patients and their parents.

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