Recovery from symptoms using an extensively hydrolyzed formula with synbiotic in infants with presumed cow's milk allergy

Objective Extensively hydrolyzed formulas (eHF) are the first‐line approach for cow's milk protein allergy (CMPA). This study evaluated the effects of eHF with synbiotic eHF (SeHF) on the general condition and symptoms of presumed CMPA infants during the initial 4‐week exclusion diet period. Methods This observational prospective study (NCT04893330) recruited 114 patients (intention‐to‐treat [ITT] population; aged ≤8 months) with presumed CMPA. Patients were followed up for 28 days (D28) (per‐protocol [PP], n = 80). Changes in general condition and presumed allergic symptoms were assessed using a 4‐level Likert scale. Secondary endpoints included the time to symptom improvement, formula acceptability and consumption, and the parent's quality of life (QoL). Results The presumed allergic symptoms had improved/resolved for 86.3% of the PP population in 7–10 days on average. 86.8% of ITT cases had digestive symptoms at baseline and those reduced/disappeared in 93.2% of the PP cases at D28. The majority of parents agreed that the formula was suitable for the baby (78.8%). The QoL significantly improved from 60 ± 28 to 42 ± 24 ( p < 0.001). Conclusion This study reflects the real‐world management of presumed CMPA in our private practices using SeHF, which effectively improved CMPA symptoms. It also highlights the importance of waiting at least 2 weeks before reconsidering CMPA diagnosis.