%0 Journal Article
%A Neumer, Franka
%A Urraca, Orenci
%A Alonso, Joaquin
%A Palencia, Jesús
%A Varea, Vicente
%A Theis, Stephan
%A Rodriguez-Palmero, Maria
%A Moreno-Muñoz, José Antonio
%A Guarner, Francisco
%A Veereman, Gigi
%A Vandenplas, Yvan
%A Campoy, Cristina
%T Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial.
%D 2021
%U http://hdl.handle.net/10668/17715
%X 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®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 n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p 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 n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p
%K efficacy
%K infant formula
%K infection
%K inulin
%K oligofructose
%K prebiotic
%K safety
%~