4.1. Study Design and Participants
weight gain, CMPA, EHF
This controlled, double-blind, randomized, multicenter, interventional clinical trial of two parallel formula-fed groups (Registration: NCT03085134) was conducted to assess the noninferiority in weight gain per day in infants with CMPA being fed an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO), compared to that of a control EHF formula. Full-term, non-breastfed infants aged 0–6 months with physician-diagnosed CMPA were enrolled. Further details of the study design and population were published by Vandenplas et al. [