1. This randomized placebo-controlled clinical trial found that the daily use of Streptococcus salivarius K12 probiotics did not decrease the incidence of acute otitis media among children attending day care.
Evidence Rating Level: 1 (Excellent)
AOM is a prevalent infection in children and a major contributor to antibiotic use in children. With the need for novel prevention strategies, this double-blind, randomized, placebo-controlled trial conducted across 50 day care centers in Finland assessed the efficacy of S. salivarius K12 probiotics in preventing AOM among children attending day care. 827 children (mean [SD] age, 4.1 [1.6] years; 47.6% girls) were enrolled and randomized in a 1:1 ratio to receive either the S salivarius K12 probiotic or a placebo for six months. The primary outcome assessed was the incidence of AOM requiring antimicrobial therapy, with 8.2% (34 children) in the probiotic group and 5.8% (24 children) in the placebo group experiencing at least one episode, resulting in a non-significant relative risk of 1.42 ([95% CI, 0.86-2.34]; proportion difference, −2.44% [95% CI −5.94% to 1.09%]; P=.17). The mean time to the first AOM episode did not differ significantly between groups, with 174 days in the S. salivarius group and 176 days in the placebo group (P=.18). Recurrent otitis media (≥3 AOM episodes in 6 months) was also similar between the probiotic (1.0%) and placebo (0.5%) groups (proportion difference, −0.50% [95% CI, −1.81% to 0.84%]; P=.41). Overall, these findings indicate that S. salivarius K12 does not confer a reduction in AOM incidence and highlight the need for continued research into effective AOM primary prevention strategies.
Click to read the study in JAMA Network Open
Image: PD
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