title: Assessment of the safety, tolerance, and protective effect against diarrhea of infant formulas containing mixtures of probiotics or probiotics and prebiotics in a randomized controlled trial.
abstract: BACKGROUND
  Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants.
  
  
  OBJECTIVE
  The objective was to evaluate infant formulas containing probiotics and synbiotics (combinations of probiotics and prebiotics) for safety and tolerance.
  
  
  METHODS
  In a prospective, controlled, double-blind, randomized trial, healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 (BL999) + Lactobacillus rhamnosus LPR (LPR), BL999 + LPR + 4 g/L of 90% galactooligosaccharide/10% short-chain fructooligosaccharide (GOS/SCFOS), or BL999 + Lactobacillus paracasei ST11 (ST11) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age (treatment period). Safety and tolerance were assessed based on weight gain during the treatment period (primary outcome) as well as recumbent length, head circumference, digestive tolerance, and adverse events (secondary outcomes), which were evaluated at 2, 4, 8, 12, 16, and 52 wk of age.
  
  
  RESULTS
  Two hundred eighty-four infants were enrolled. During the treatment period, difference in mean weight gain between control and study formula groups in both the intention-to-treat and per-protocol populations were within the predefined equivalence boundaries of +/-3.9 g/d, indicating equivalent weight gain. Secondary outcomes did not show significant differences between groups during the treatment period.
  
  
  CONCLUSIONS
  Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well.
authors.affiliation: Gastroenterology and Nutrition Unit, Department of Pediatrics, Centre Hospitalier Universitaire de Grenoble, Grenoble, France. jpchouraqui@chu-grenoble.fr
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Chouraqui
authors.forename: Dominik
authors.initials: D
authors.lastname: Grathwohl
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Labaune
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Hascoet
authors.forename: Ines
authors.initials: I
authors.lastname: de Montgolfier
authors.forename: Michèle
authors.initials: M
authors.lastname: Leclaire
authors.forename: Mariana
authors.initials: M
authors.lastname: Giarre
authors.forename: Philippe
authors.initials: P
authors.lastname: Steenhout
mesh_terms: D001644:Bifidobacterium / Q000254:growth & development / Q000502:physiology*; D001827:Body Height / Q000502:physiology; D001835:Body Weight / Q000502:physiology; D015169:Colony Count, Microbial; D003257:Consumer Product Safety; D003968:Diarrhea, Infantile / Q000517:prevention & control*; D004063:Digestion; D004311:Double-Blind Method; D005260:Female; D006257:Head / Q000033:anatomy & histology; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007778:Lactobacillus / Q000254:growth & development / Q000502:physiology*; D052201:Lacticaseibacillus rhamnosus / Q000254:growth & development / Q000502:physiology; D008297:Male; D009844:Oligosaccharides / Q000008:administration & dosage* / Q000009:adverse effects; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D015430:Weight Gain
chemical_list: D009844:Oligosaccharides