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

Abstract

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, <i>n</i> = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti^®Synergy1 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 <i>n</i> = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (<i>p</i> < 0.05). The prebiotic group showed higher <i>Bifidobacterium</i> counts at month 6 (<i>p</i> = 0.006), and higher proportions of <i>Bifidobacterium</i> in relation to total bacteria at month 2 and 6 (<i>p</i> = 0.042 and <i>p</i> = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (<i>p</i> < 0.05). Orafti^®Synergy1 tended to beneficially impact total daily amount of crying (<i>p</i> = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher <i>Bifidobacterium</i> levels at the first 6 months of life, and is associated with reduced duration of infections.