RT Journal Article
T1 Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial.
A1 Neumer, Franka
A1 Urraca, Orenci
A1 Alonso, Joaquin
A1 Palencia, Jesús
A1 Varea, Vicente
A1 Theis, Stephan
A1 Rodriguez-Palmero, Maria
A1 Moreno-Muñoz, José Antonio
A1 Guarner, Francisco
A1 Veereman, Gigi
A1 Vandenplas, Yvan
A1 Campoy, Cristina
K1 efficacy
K1 infant formula
K1 infection
K1 inulin
K1 oligofructose
K1 prebiotic
K1 safety
AB 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
YR 2021
FD 2021-04-13
LK http://hdl.handle.net/10668/17715
UL http://hdl.handle.net/10668/17715
LA en
DS RISalud
RD Apr 15, 2025