title: Probiotics and prebiotics in preventing episodes of acute otitis media in high-risk children: a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  Several studies have suggested that probiotics (proB) and/or prebiotics (preB) could reduce the burden of infection in infants and toddlers. We aimed to determine whether follow-up formula supplemented with proB and preB could reduce the risk of acute otitis media (AOM).
  
  
  METHODS
  In this double-blind, placebo-controlled trial from November 2007 to April 2009, 37 pediatricians in France enrolled children 7 to 13 months of age with high risk of AOM who were randomly assigned to receive follow-up formula supplemented with proB (Streptococcus thermophilus NCC 2496, Streptococcus salivarius DSM 13084, Lactobacillus rhamnosus LPR CGMCC 1.3724) and preB (Raftilose/Raftiline) or follow-up formula alone (placebo). During 12 months, the 2 groups were compared for number of AOM episodes diagnosed (primary outcome) and secondary outcomes by the Poisson model (incidence rate ratio [IRR]) or logistic regression (odds ratio; and 95% confidence interval [95% CI]) after adjustment on covariates of interest.
  
  
  RESULTS
  We enrolled 224 children (112 in each group). All children were vaccinated (4 doses) with the 7-valent pneumococcal conjugate vaccine; demographic characteristics were similar in the 2 groups. In total, 486 AOM episodes were reported, 249 and 237 in the treatment and control groups, respectively. The treatment and control groups did not differ in incidence of AOM (IRR 1.0, 95% CI: 0.8-1.2), lower respiratory tract infections (IRR 0.9, 0.7-1.2) or number of antibiotic treatment courses (IRR = 1.0, 95% CI: 0.8-1.2). Treatment was not associated with recurrent AOM (odds ratio 1.0, 95% CI: 0.5-1.7). With regard to gastrointestinal disorders, both formulas were well tolerated.
  
  
  CONCLUSIONS
  The proB and preB included in follow-up formula given to children at 7 to 13 months of age did not reduce the risk of AOM, recurrent AOM, antibiotic use or lower respiratory tract infections at 1 year.
authors: Association Clinique et Thérapeutique Infantile du Val de Marne, Paris, France. robert.cohen@wanadoo.fr
authors: Robert
authors: R
authors: Cohen
authors: Elvira
authors: E
authors: Martin
authors: France
authors: F
authors: de La Rocque
authors: Franck
authors: F
authors: Thollot
authors: Sophie
authors: S
authors: Pecquet
authors: Andreas
authors: A
authors: Werner
authors: Michel
authors: M
authors: Boucherat
authors: Emmanuelle
authors: E
authors: Varon
authors: Edouard
authors: E
authors: Bingen
authors: Corinne
authors: C
authors: Levy
mesh_terms: D000208:Acute Disease; D001419:Bacteria / Q000145:classification / Q000302:isolation & purification; D001424:Bacterial Infections / Q000453:epidemiology / Q000382:microbiology; D002353:Carrier State / Q000453:epidemiology / Q000382:microbiology; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D007223:Infant; D009305:Nasopharynx / Q000382:microbiology; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage; D056692:Prebiotics; D019936:Probiotics / Q000627:therapeutic use*; D016896:Treatment Outcome; D018074:Vaccines, Conjugate / Q000008:administration & dosage
chemical_list: D022242:Pneumococcal Vaccines; D056692:Prebiotics; D018074:Vaccines, Conjugate