Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy: a randomized controlled clinical trial

Consecutive patients affected by IgE- or non-IgE-mediated CMA, aged <= 4 years, were enrolled. DBPCFC was carried out with increasing doses of the new Aaf (Sineall, Humana, Milan, Italy), using validated Aaf as placebo. Faecal concentrations of calprotectin (FC) and eosinophilic cationic protein (ECP) were monitored.Sixty patients (44 male, 73.3%, median age 37, 95%CI 34.5--39.6 months, IgE-mediated CMA 29, 48.3%) were enrolled. At the diagnosis clinical symptoms were gastrointestinal (46.6%), cutaneous (36.6%), respiratory (23.3%), and systemic (10.0%). After DBPCFC with the new Aaf, no patient presented early or delayed clinical reactions. Faecal concentration of calprotectin and of ECP remained stable after the exposure to the new Aaf.The new Aaf is well tolerated in children with IgE- or non-IgE-mediated CMA, and it could be used as a safe dietotherapy regimen for children with this condition.Trial registration: The trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT01622426).