Study of Functional Gastrointestinal Disorders in Infants Using a New Symbiotic Infant Formula Over Four Months

What this Trial Is About

Researchers are studying infants with functional gastrointestinal disorders FGIDs to see how these conditions change when fed a new infant formula. This open-label, interventional, non-comparative multicenter study uses the Gastrointestinal and Gastroesophageal Reflux GIGER scale to evaluate symptoms like regurgitations, colic, and constipation. The study focuses on infants up to 4 months old who have at least one FGID based on adapted Rome IV criteria. The study involves feeding infants a thickened infant formula containing fibers and probiotics over two periods a first 30-day period followed by an optional 90-day intervention period. The new formula is given continuously during the total 4-month study duration. Researchers will monitor various symptoms and digestive functions using the GIGER scale and other assessments throughout these periods. Participants will be evaluated regularly with measures including regurgitation frequency and severity, stool characteristics, colic, gas severity, abdominal distension, sleep quality, infant growth parameters, and quality of life. Parents will also report satisfaction. Safety is monitored by recording any adverse events through study completion. The primary outcome is the change in GIGER score from baseline at Day 30, with ongoing assessments up to Day 120 for those continuing in the optional period.

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