title: Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial.
abstract: BACKGROUND
  Prebiotics and probiotics exert beneficial effects by modulating gut microbiota and immune system. This study evaluates efficacy and safety of an infant formula containing bovine milk-derived oligosaccharides and Bifidobacterium animalis ssp lactis (B. lactis) (CNCM I-3446) on incidence of diarrhea and febrile infections during the first year of life (primary outcome).
  
  
  METHODS
  Full-term infants receiving Test or Control (without bovine milk-derived oligosaccharide and B. lactis) formulae were enrolled in a multicenter, randomized, controlled, and double-blind trial with a reference breastfeeding group. .
  
  
  RESULTS
  413 infants were assigned between Test (n = 206) and Control (n = 207) formula. There was no significant difference for diarrhea and febrile infections incidence between groups at 6 (odds ratio (95% confidence interval) = 0.56 (0.26-1.15), P = 0.096) and 12 mo (odds ratio = 0.66 (0.38-1.14), P = 0.119). Test formula was well tolerated, anthropometrics parameters were not significantly different between groups and aligned with WHO growth standards up to 12 mo. Data from test group showed that gut microbiota pattern, fecal IgA and stool pH were brought to be closer to those of breastfed infants.
  
  
  CONCLUSIONS
  An infant formula enriched with bovine milk-derived oligosaccharide and B. lactis supports normal infant growth, is well tolerated and improves intestinal health markers. No differences in diarrhea and febrile infection incidence were found in the population studied.
authors.affiliation: Klinik für Kinder und Jugendmedizin, Klinikum Westbrandenburg GmbH, Potsdam, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Radke
authors.affiliation: Service de Réanimation Néonatale, Hôpital de la Croix Rousse, Lyon, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Picaud
authors.affiliation: Klinik für Neonatologie, Charité Campus Virchow-Klinikum, Berlin, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Loui
authors.affiliation: Service de Pédiatrie 2, Hôpital Arnaud de Villeneuve, Montpellier, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Cambonie
authors.affiliation: Zentrum für Kinderheilkunde & Jugendmedizin, Universitätsklinikum Gießen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Faas
authors.affiliation: Afdeling Kindergeneeskunde, Vrije Universiteit Medisch Centrum, Amsterdam, The Netherlands.
authors.forename: Harry N
authors.initials: HN
authors.lastname: Lafeber
authors.affiliation: Research & Development, Nestlé Nutrition, Vevey, Switzerland.
authors.forename: Nanda
authors.initials: N
authors.lastname: de Groot
authors.affiliation: Research & Development, Nestlé Nutrition, Vevey, Switzerland.
authors.forename: Sophie S
authors.initials: SS
authors.lastname: Pecquet
authors.affiliation: Medical Nutrition, Nestle Health Science, Vevey, Switzerland.
authors.forename: Philippe G
authors.initials: PG
authors.lastname: Steenhout
authors.affiliation: Maternité Régionale Universitaire A. Pinard, CHRU, Nancy, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Hascoet
mesh_terms: D000818:Animals; D000069982:Bifidobacterium animalis; D001942:Breast Feeding; D002417:Cattle; D003967:Diarrhea / Q000382:microbiology; D004311:Double-Blind Method; D005334:Fever; D000069196:Gastrointestinal Microbiome; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007107:Immune System; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007422:Intestines / Q000502:physiology*; D053208:Kaplan-Meier Estimate; D008892:Milk / Q000737:chemistry; D008895:Milk, Human / Q000737:chemistry; D016017:Odds Ratio; D009844:Oligosaccharides / Q000737:chemistry; D056692:Prebiotics; D019936:Probiotics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D009844:Oligosaccharides; D056692:Prebiotics