Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial.

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of OraftiSynergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants ( < 0.05). The prebiotic group showed higher counts at month 6 ( = 0.006), and higher proportions of in relation to total bacteria at month 2 and 6 ( = 0.042 and = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer ( < 0.05). OraftiSynergy1 tended to beneficially impact total daily amount of crying ( = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher levels at the first 6 months of life, and is associated with reduced duration of infections.