Neumer, FrankaUrraca, OrenciAlonso, JoaquinPalencia, JesúsVarea, VicenteTheis, StephanRodriguez-Palmero, MariaMoreno-Muñoz, José AntonioGuarner, FranciscoVeereman, GigiVandenplas, YvanCampoy, Cristina2023-02-092023-02-092021-04-13http://hdl.handle.net/10668/17715The 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 (penAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/efficacyinfant formulainfectioninulinoligofructoseprebioticsafetyBifidobacteriumBiomarkersBottle FeedingDouble-Blind MethodFecesFemaleGastrointestinal MicrobiomeHumansIncidenceInfantInfant FormulaInfant, NewbornInfectionsIntention to Treat AnalysisInulinMalePrebioticsProspective StudiesTime FactorsTreatment Outcomeresearch article33924514open access10.3390/nu130412762072-6643PMC8070502https://www.mdpi.com/2072-6643/13/4/1276/pdf?version=1618480294https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8070502/pdf