Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

This study assesses whether a new infant formula reduces common digestive problems in babies — such as spitting up, colic, and constipation — over a 30-day period (with an optional 90-day extension). These functional gastrointestinal disorders are very common in the first months of life and can cause significant distress for infants and families. Eligible participants are formula-fed infants up to 4 months old who were born at 35 weeks or later and are currently experiencing at least one of these digestive issues. Participation involves switching the baby to the study formula and having parents track symptoms using a standardized scale at regular clinic visits over the study period. This summary was prepared to help patients understand the study in plain language.