Growth and Tolerance Trial on Infant Formula with 2’-Fucosyllactose: Stardust Trial
Dr. Stephanie Oliveira, Assistant Professor of Pediatrics in Gastroenterology, would like to inform providers about an ongoing formula study which compares standard formula to formula with the addition of 2’-fucosyllactose (2’-FL). The third largest component in human milk, after lactose and fat, are the human milk oligosaccharides (HMOs). HMOs are indigestible by the infant and serve as substrates for select bacteria, thereby contributing to shaping the infant gut microbiome. The most abundant HMO in human milk is 2’-FL. Clinical association studies have indicated that infants receiving human milk with low concentrations of 2’-FL show delayed establishment of bifidobacteria in the gut microbiota, have an increased risk of diarrhea, and of developing allergy as compared to infants receiving high levels of 2’-FL in their milk. FrieslandCampina Domo, an ingredient supplier for infant nutrition based in the Netherlands, has recently developed a 2’-FL supplement named Aequival®. Aequival® 2’-FL has recently been officially certified to be used in infant formula in both European and US markets. All formula will be supplied through the study. No blood draws are required. An exclusively breastfed study arm has already filled.
Please consider sharing this patient flyer with families of newborns. If your practice is interested in partnering with her in recruitment, please contact Dr. Oliveira or her study coordinator Andre Hawkins. Compensation will be provided to practices who enroll patients. More information is available in study summary found HERE.