GRANDIOSA - Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

What this Trial Is About

This research aims to study healthy infants to evaluate the effects of two new partially hydrolysed infant formulae on growth, immune system markers, neurodevelopment, protein metabolism, and gut bacteria. The study compares these new formulas to standard infant formula and to breastmilk. The goal is to better understand how these formulas influence infant growth patterns and health outcomes, especially since formula-fed infants tend to gain weight faster than breastfed infants and have different health risks. Infants are randomly assigned to one of four groups: two groups receive different new hydrolysed formulas, one group receives a standard infant formula, and the last group includes infants who are exclusively breastfed. The study follows European Food Safety Authority guidelines for novel hydrolysed protein formulas. The primary measurement is the change in weight standard deviation score from birth until 5 months old. Participants are enrolled between 4 and 8 weeks old and will be followed monthly from 2 to 5 months of age for measurements including length, head circumference, body composition, gastrointestinal health, allergy symptoms, immune activity, metabolic markers, protein metabolism, gut microbiota, and neurodevelopmental assessments at 6 months, 12 months, and 3 years. The study collects detailed health data to monitor growth, development, and immune responses over time, ensuring comprehensive long-term follow-up.

Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula