An open-label study to evaluate the effects of Streptococcus salivarius K12 given as a powder formula to prevent respiratory infections in young children

Abstract

The purpose of this study was to evaluate the efficacy and safety of Bactoblis® sachets containing Streptococcus salivarius K12 (minimum 1 billion CFU/sachet) in preventing acute respiratory infections in young children who had just started attending a kindergarten. This open-label, single-centre, randomized (1:1), controlled clinical study was conducted between February 2019 and December 2019 at the Poltava Regional Children’s Clinical Hospital of the Poltava Regional Council. The randomization of patients in the study was performed by random sampling in a ratio of 1:1. A total of 58 healthy children aged between two to four years were enrolled; 28 children received a Bactoblis® sachet once daily for 90 days and 30 children who did not receive Bactoblis® served as the control. The effectiveness of prophylactic administration of the Bactoblis® sachet was assessed as a reduction in the incidence of tonsillopharyngitis, tracheitis, rhinitis, laryngitis and otitis media. Other outcomes assessed were the requirement to administer antibacterial agents and antipyretics, and the frequency of absence from preschool institutions during the treatment period, and within six months of follow-up. Children who received Bactoblis® for 90 days had a significant reduction in the incidence of infections during treatment and within six months of follow-up compared to those in the control group (p<0.01). There was a significant reduction in the use of antipyretics in children treated with the probiotic supplement, and antibiotics were used for a shorter duration compared to the control group (p<0.01). In addition, the number of days absent from preschool was lower in children treated with Bactoblis® compared to the control group (p<0.01). No side effects were observed during the study, and 92.9% of patients reported excellent tolerability to the product. Our results show that treatment with a Bactoblis® sachet for 90 days was effective in preventing acute respiratory infections in children aged between two to four years. The authors suggest that this could be a useful supplementary probiotic for restoring natural microflora after antibiotic therapy, thus preventing the development of bacterial complications, and increasing resistance to viral infections during seasonal diseases and in organized children’s communities.