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

Randomized trialEuropean journal of pediatrics· Sep 2026

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

Caroline Halley, Claire Honeywill, Janice Kang … Julian Crane

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Pediatric ENTRandomized trialQ1IF 3.2

Daily Streptococcus salivarius K12 did not significantly reduce acute otitis media in infants from the general population.

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

Caroline Halley … Julian Crane

European journal of pediatrics · Sep 2026

Background

UNLABELLED: Acute otitis media (acute otitis media) and respiratory tract infections are common in early childhood and are major contributors to antibiotic use.

Purpose

We aim to determine the efficacy of S. salivarius K12 in preventing acute otitis media in the general infant population.

Methods

A total of 428 children were randomised by household and 368 (86%) contributed primary outcome data (placebo n = 180; active n = 188).

n = 428 children

Results

probiotic group had a lower acute otitis media rate than placebo, but the difference could be chance

RR 0.84 (95% CI 0.57 to 1.24)

null 1

0.57

1.24

CI crosses the null - not significant

More results

The oral probiotic Streptococcus salivarius K12 has demonstrated antimicrobial and immunomodulatory activity in vitro, and preventive effects in children with recurrent acute otitis media.

The primary outcome was the rate of doctor-recorded acute otitis media.

Time to first acute otitis media episode did not significantly differ (hazard ratio 0.89, 95% CI 0.63-1.26).

More results

No significant differences were observed for acute otitis media severity, respiratory infections, antibiotic prescribing or healthcare utilisation.

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Conclusion

Daily oral S. salivarius K12 did not reduce acute otitis media incidence or respiratory infections in children under 2 years; therefore, routine use for acute otitis media prevention in general paediatric populations is not supported.

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

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

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