title: Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1-6 months of age: a randomized controlled trial.
abstract: The objective of the study was to evaluate the safety and tolerance of an infant formula supplemented with Lactobacillus fermentum CECT5716, a probiotic strain isolated from breast milk, in infants of 1-6 months of age. A randomized double blinded controlled study including healthy infants was conducted. One month aged infants received a prebiotic infant formula supplemented with L. fermentum (experimental group) or the same formula without the probiotic strain (control group) for 5 months. The primary outcome of the study was average daily weight gain between baseline and 4 months of age. Secondary outcomes were other anthropometric data (length and head circumference), formula consumption, and tolerance. Incidence of infections was also recorded by pediatricians. No significant differences in weight gain were observed between both groups, neither at 4 months of age (29.0±7.8 vs 28.9±5.7g/day) nor at 6 months (25.1±6.1 vs 24.7±5.2g/day). There were no statistically significant differences in the consumption of the formulae or symptoms related to the tolerance of the formula. The incidence rate of gastrointestinal infections in infants of the control group was 3 times higher than in the probiotic group (p=0.018). Therefore, consumption of a prebiotic infant formula enriched with the human milk probiotic strain L. fermentum CECT5716 from 1 to 6 months of life is well tolerated and safe. Furthermore, the consumption of this formula may improve the health of the infants by reducing the incidence of gastrointestinal infections.
authors.affiliation: Hospital Universitario Reina Sofía, Avenida Menéndez Pidal S/N, Córdoba, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Gil-Campos
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: López
authors.forename: M Victoria
authors.initials: MV
authors.lastname: Rodriguez-Benítez
authors.forename: Julio
authors.initials: J
authors.lastname: Romero
authors.forename: Inés
authors.initials: I
authors.lastname: Roncero
authors.forename: M Dolores
authors.initials: MD
authors.lastname: Linares
authors.forename: Jose
authors.initials: J
authors.lastname: Maldonado
authors.forename: Eduardo
authors.initials: E
authors.lastname: López-Huertas
authors.forename: Regina
authors.initials: R
authors.lastname: Berwind
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Ritzenthaler
authors.forename: Victor
authors.initials: V
authors.lastname: Navas
authors.forename: Carlos
authors.initials: C
authors.lastname: Sierra
authors.forename: Lluis
authors.initials: L
authors.lastname: Sempere
authors.forename: Arjan
authors.initials: A
authors.lastname: Geerlings
authors.forename: Jose A
authors.initials: JA
authors.lastname: Maldonado-Lobón
authors.forename: Antonio D
authors.initials: AD
authors.lastname: Valero
authors.forename: Federico
authors.initials: F
authors.lastname: Lara-Villoslada
authors.forename: Mónica
authors.initials: M
authors.lastname: Olivares
mesh_terms: D000886:Anthropometry / Q000379:methods; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D052197:Limosilactobacillus fermentum; D008297:Male; D008895:Milk, Human / Q000382:microbiology; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects*; D015430:Weight Gain