1. Introduction
milk, ’ gastrointestinal tolerance, gastrointestinal (GI) disturbances, human milk or infant formula, weight gain
SECONDARY, DISEASES
Membership of the HASI Study Group is provided in the Acknowledgements.The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow’s milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants’ gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: Human milk is the gold standard for infant feeding, not only regarding nutritional needs of infants but also for providing bioactive components and ultimately reducing the risk of diseases later in life [Regardless of feeding with human milk or infant formula, a high incidence of gastrointestinal (GI) disturbances is observed in infants [Different types of infant formula have been developed in order to meet different needs; each is required to conform to the requirements set out by the European Food Safety Authority (EFSA). Most products are based on cow’s milk protein and are supplemented with nutrients or other bioactive components, such as long-chain unsaturated fatty acids, milk oligosaccharides, and probiotics, in order to best mimic human milk both in nutrient composition and GI tolerance. Studies have suggested that infant formula manufactured from hydrolysed protein may positively affect digestibility and GI symptoms during the first months of life due to the different molecular structures of proteins and peptides [The purpose of the analysis of the secondary outcome parameters of the “HA Safety in Infants” (HASI) Study was to evaluate the GI tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to an infant formula manufactured from intact protein (control formula, CF) during the first 120 days of life using several well-validated parameters. Exclusively breastfed infants were included for descriptive purposes. Safety and suitability, i.e., weight gain and other growth parameters, of eHF for infant consumption have already been demonstrated within the HASI Study [