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
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.
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.
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.