Efficacy of administering Streptococcus salivarius K12 as a powder formula in preventing respiratory infections in infants

Abstract

The purpose of this study was to evaluate the efficacy and safety of Bactoblis® as a powder (sachets), containing Streptococcus salivarius K12 (minimum 1 billion CFU/sachet) for the prevention of respiratory diseases in young children. This open-label, single-centre, randomized, controlled clinical study was conducted between February 2019 and December 2019 at a Children’s Clinical Hospital belonging to the Department of Pediatrics of the Ukrainian Medical and Dental Academy. Of the 62 children aged six months to two years enrolled, 32 children received a Bactoblis® sachet once daily for 30 days. The children who did not receive Bactoblis® sachets (n=30) served as the control group. The efficacy of prophylactic administration of Bactoblis® sachets was evaluated in terms of a reduction in the incidence of acute respiratory viral infection (ARVI) episodes, the presence of bacterial complications after a respiratory infection, a need for antibacterial agents and antipyretics and the frequency of visits to an otorhinolaryngologist during the 30-day treatment period and within 90 days of follow-up. Children treated with Bactoblis® sachets had a significant reduction in the incidence of ARVI episodes compared to those in the control group (p<0.01). The frequency of antipyretic use and otorhinolaryngologist visits was lower in children receiving prophylactic treatment with Bactoblis® sachets compared to the control group (p<0.01). The incidence of bacterial complications and the requirement for antibacterial agents were reduced in children using Bactoblis® sachets compared to the control group (p<0.01). No side effects were observed during the study, and 93.8% of patients reported tolerability of the product as excellent. Our findings indicate that treatment with Bactoblis® in a powder format for 30 days is effective in preventing ARVI episodes in young children (six months to two years). Our results are in line with those reported in previous studies that evaluated Bactoblis® lozenges in children and in adults. This is proposed to be a useful supplementary probiotic for preventing respiratory infections during seasonal diseases and within organized children’s communities.