Maromme

Researchers are studying the effectiveness and tolerance of a new anti-regurgitation infant formula designed to reduce regurgitation episodes in infants with gastroesophageal reflux. This randomized, controlled, double-blind trial compares the new formula thickened with fibers to a formula thickened with locust bean gum. The goal is to assess how well the new formula reduces regurgitation frequency and its effects on digestive tolerance. Participants will exclusively feed their infants either the experimental formula or the comparator formula during the study. The study lasts for 1 month and 2 days, beginning with a 2-day pre-selection period, followed by a 30-day follow-up period. There is an optional additional 2-month follow-up phase to further monitor the infants. During the study, parents and researchers will track the frequency of regurgitation on day 14 as the primary outcome. Other assessments include monitoring digestive tolerance and overall infant health. Parents provide informed consent and participate in feeding and observation activities throughout the study duration, which may last up to 3 months if the optional follow-up is added.