Probiotics and Prebiotics in Preventing Episodes of Acute Otitis Media in High-Risk Children: A Randomized, Double-Blind, Placebo-Controlled Study
The Pediatric infectious disease journal | 23 Feb 2013
R Cohen, E Martin, F de La Rocque, F Thollot, S Pecquet, A Werner, M Boucherat, E Varon, E Bingen and C Levy
BACKGROUND AND AIMS:: 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 old 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 [OR]; 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 (OR 1.0, 95% CI 0.5-1.7). Regarding gastrointestinal disorders, both formulas were well tolerated. CONCLUSION:: The proB and preB included in follow-up formula given to chidren 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.
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