title: Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children.
abstract: OBJECTIVE
  Intestinal microbiota plays an important role in the prevention of certain diseases during the pediatric years. Thus, there is an increasing interest in the addition of probiotics to infant formulas. The aim of this study was to evaluate the safety of a follow-on formula with Lactobacillus salivarius CECT5713 in 6-mo-old children.
  
  
  METHODS
  The antibiotic susceptibility of L. salivarius CECT5713 was analyzed by a dilution method. A double-blinded, randomized, placebo controlled study was performed. Children (n = 80) were distributed in two groups and consumed the formula supplemented or not with probiotics (2 × 10(6) colony-forming units [cfu]/g) during 6 mo. Fecal samples were collected at enrollment, at 3 mo, and at the end of trial. Clinical and anthropometric evaluations were performed. Depending on the variable, one-way or two-way repeated measures analysis of variance were used for the statistical analysis.
  
  
  RESULTS
  The antibiotic susceptibility profile of the strain resulted as safe. No adverse effects associated with the consumption of the probiotic formula were reported. In addition, clinical parameters did not differ between groups. Consumption of the probiotic supplemented formula led to an increase in the fecal lactobacilli content (7.6 ± 0.2 versus 7.9 ± 0.1 log cfu/g, P < 0.05). Lactobacillus salivarius CECT5713 was detected in the feces of volunteers from the probiotic group. Probiotic consumption induced a significant increase in the fecal concentration of butyric acid at 6 mo.
  
  
  CONCLUSIONS
  Thus, a follow-on formula with L. salivarius CECT5713 is safe and well tolerated in 6-mo-old infants.
authors.affiliation: Department of Pediatrics, Hospital Universitario San Cecilio, Granada, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Maldonado
authors.forename: Federico
authors.initials: F
authors.lastname: Lara-Villoslada
authors.forename: Saleta
authors.initials: S
authors.lastname: Sierra
authors.forename: Lluis
authors.initials: L
authors.lastname: Sempere
authors.forename: Marta
authors.initials: M
authors.lastname: Gómez
authors.forename: Juan Miguel
authors.initials: JM
authors.lastname: Rodriguez
authors.forename: Julio
authors.initials: J
authors.lastname: Boza
authors.forename: Jordi
authors.initials: J
authors.lastname: Xaus
authors.forename: Mónica
authors.initials: M
authors.lastname: Olivares
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology; D020148:Butyric Acid / Q000032:analysis; D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005516:Food Microbiology; D041981:Gastrointestinal Tract / Q000502:physiology; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007778:Lactobacillus / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification; D008297:Male; D008826:Microbial Sensitivity Tests; D050296:Microbial Viability; D008895:Milk, Human / Q000382:microbiology*; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000517:prevention & control; D013997:Time Factors; D014867:Water / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D014867:Water; D020148:Butyric Acid