@misc{10481/68389, year = {2021}, month = {4}, url = {http://hdl.handle.net/10481/68389}, 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, n = 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(R)Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 degrees 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 n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti(R)Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.}, organization = {European Commission FOOD-CT-2005-007036}, publisher = {MDPI}, keywords = {Inulin}, keywords = {Oligofructose}, keywords = {Prebiotic}, keywords = {Infant formula}, keywords = {Safety}, keywords = {Efficacy}, keywords = {Infection}, title = {Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial}, doi = {10.3390/nu13041276}, author = {Neumer, Franka and Campoy Folgoso, Cristina}, }