Amino Acid-based Formula in Cowʼs Milk Allergy: Long-term Effects on Body Growth and Protein Metabolism. A Randomized Trial

Objectives. The long-term effects of amino acid–based formula (AAF) in the treatment of cow’s milk allergy (CMA) is largely unexplored. This study comparatively evaluates body growth and Copyright © ESPGHAN and NASPGHAN. All rights reserved. protein metabolism in CMA children treated with AAF or with extensively hydrolysed whey formula (eHWF), and healthy controls (HCs). Methods. A 12-month multicentre randomised control trial (RCT) was conducted in outpatients with CMA (aged 5–12 m) randomised in two groups, treated with AAF (Group 1) and eHWF (Group 2), and compared with HCs (Group 3) fed with follow-on (if age <12 m) or growing-up formula (if age >12 m). At enrolment (T0), after 3 (T3), 6 (T6) and 12 months (T12) a clinical evaluation was performed. At T0 and T3, were dosed in CMA subjects serum levels of albumin, urea, total protein, retinol binding protein, and insulin-like growth factor 1 (IGF-1). Results. 21 subjects in Group 1 (61.9% male, aged 6.5 ±1.5 m), 19 in Group 2 (57.9% male, aged 7 ±1.7 m) and 25 subjects in Group 3 (48% male, aged 5.5±0.5 m) completed the study. At T0, the weight z-score was similar in Group 1 (−0.74) and 2 (−0.76), with differences compared to Group 3 (−0.17, p < 0.05). At T12, the weight z-score value was similar between the three groups without significant differences. There were no significant changes in protein metabolism in children in Groups 1 and 2. Conclusions. Long-term treatment with AAF is safe and allows adequate body growth in CMA children without alterations in protein metabolism.