Evaluation of a New Fiber-Thickened Infant Formula for Reducing Regurgitation in Young Children with Gastroesophageal Reflux

What this Trial Is About

Researchers are evaluating a new anti-regurgitation infant formula to see how well it reduces regurgitation episodes and improves digestive tolerance in infants with gastroesophageal reflux. This is a randomized, controlled, double-blind trial comparing the new formula to a standard thickened formula. The study is sponsored by United Pharmaceuticals and focuses on infants between 2 weeks and 4 months old. The study includes two groups one receiving the new formula thickened with fibers and the other receiving a formula thickened with locust bean gum. The trial lasts for 1 month and 2 days, starting with a 2-day pre-selection period followed by a 30-day follow-up. Participants can optionally continue for an additional 2 months of follow-up from day 30 to day 90. During the study, infants will be monitored for the frequency and severity of regurgitations, digestive symptoms like diarrhea and constipation, feeding behaviors, sleep quality, and growth measurements including weight, length, head circumference, and BMI. Parents and investigators satisfaction will also be recorded. These assessments occur at days 14, 30, and 90. The primary outcome is the frequency of regurgitation at day 14. All study visits and evaluations are conducted under careful monitoring to track safety and treatment effects.

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)