RT Journal Article T1 Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial. A1 Rodriguez-Herrera, Alfonso A1 Mulder, Kelly A1 Bouritius, Hetty A1 Rubio, Rocio A1 Muñoz, Antonio A1 Agosti, Massimo A1 Lista, Gianluca A1 Corvaglia, Luigi A1 Ludwig, Thomas A1 Abrahamse-Berkeveld, Marieke A1 Perez-Navero, Juan L K1 Crying K1 Fermented formula K1 Gastrointestinal symptoms K1 Growth adequacy K1 ScGOS/lcFOS K1 Sleeping K1 Stool characteristics AB This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p< 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants. PB MDPI YR 2019 FD 2019-07-03 LK http://hdl.handle.net/10668/14223 UL http://hdl.handle.net/10668/14223 LA en NO Rodriguez-Herrera A, Mulder K, Bouritius H, Rubio R, Muñoz A, Agosti M, et al. Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial. Nutrients. 2019 Jul 5;11(7):1530 DS RISalud RD Apr 5, 2025