Preventing otitis media and respiratory tract infections with the oral probiotic Streptococcus salivarius K12.

TL;DR

A double-blind randomized controlled trial found that daily oral Streptococcus salivarius K12 did not reduce acute otitis media incidence (37% vs 39% in active vs placebo) or respiratory infections in infants aged 6-24 months. Routine use for AOM prevention in general pediatric populations is not supported.

Key findings

• Doctor-recorded AOM rates were 37% in the probiotic group and 39% in the placebo group (rate ratio 0.84, 95% CI 0.57-1.24), showing no significant difference
• Secondary outcomes including time to first AOM episode, respiratory infection rates, antibiotic prescribing, and healthcare utilization showed no significant differences between groups
• Higher-adherence subgroup analyses did not reveal statistically significant benefits of the probiotic intervention
• Study enrolled 368 children (188 active, 180 placebo) from New Zealand with 86% contributing primary outcome data

Why this matters at the bedside

While S. salivarius K12 showed promise in smaller studies of children with recurrent AOM, this large RCT demonstrates it does not prevent AOM or respiratory infections in the general infant population, suggesting clinicians should not recommend routine use for this indication in otherwise healthy children.