TOPLINE

Daily use of the oral probiotic Streptococcus salivarius K12 from age 6 months to 2 years did not reduce the occurrence of acute otitis media (AOM) or respiratory tract infections (RTIs) or the use of antibiotics in healthy infants, a large trial in New Zealand showed.

METHODOLOGY

• A double-blind randomized controlled trial included 428 infants who were aged 3-6 months, were born at ≥ 28 weeks, and resided in Wellington or Christchurch, New Zealand.
• Participants received daily S. salivarius K12 (at least 1.25 × 10⁹ colony-forming units per dose; n = 188) or an identical placebo powder (n = 180) from age 6 months to 24 months.
• The primary outcome was the rate of doctor-recorded AOM during the 18-month intervention period. Secondary outcomes included medical visits for RTIs, antibiotic prescriptions, croup diagnoses, and the severity of otitis media. Parent-reported serious adverse events were also assessed.
• Outcome data were obtained from caregiver questionnaires and structured review of general practice records; 368 children had retrievable general practice outcome data.
• Recruitment ended in May 2020, with follow-up continuing until late 2021, overlapping with COVID public health restrictions in New Zealand.

TAKEAWAY

• Rates of doctor-recorded AOM were not significantly different between the probiotic group (37.23%; 109 episodes) and the placebo group (38.89%; 129 episodes).
• Secondary outcomes and parent-reported serious adverse events did not differ significantly between groups.
• Among participants with higher adherence, point estimates favored the use of the probiotic for rates of doctor-recorded AOM and medical visits for otitis media, but the differences were not statistically significant. 

IN PRACTICE

"Taken with existing placebo-controlled evidence, our findings do not support routine oral S. salivarius K12 for prevention of AOM or RTIs in the general population of infants and young children," the authors wrote.

SOURCE

The study was led by Caroline Halley, University of Otago, Wellington, New Zealand. It was published online on September 3 in the European Journal of Pediatrics.

LIMITATIONS

COVID public health restrictions altered respiratory pathogen circulation and healthcare utilization during the study period, potentially reducing opportunities to observe treatment differences. The study was also limited by lack of general practice outcome data for 14% of children and the possibility of an associated bias, and declining adherence over time.

DISCLOSURES

The study was funded by the Health Research Council of New Zealand. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.