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Study to Investigate the Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Supplementation Against Recurrent Streptococcus Pyogenes (GAS) Bacterial Pharyngotonsillitis in Children: A Randomized, Double-blind Controlled Clinical Trial
Recurrent Group A Streptococcus (GAS) infections, primarily presenting as strep throat, are a significant health concern in pediatric populations, leading to symptoms like sore throat, fever, and swollen lymph nodes. GAS is highly contagious and can spread easily among children in close-contact environments like schools and daycare centers, often resulting in frequent re-infections. Managing these recurrent infections typically requires antibiotics, but reliance on antibiotics carries risks, including resistance development, gut microbiota disruption, and various side effects. Probiotic therapy, particularly with Streptococcus salivarius K12, has shown promise as a preventive approach, utilizing competitive exclusion and antimicrobial production to inhibit GAS growth in the oral cavity. Recent studies have advanced this with the development of S. salivarius eK12, a re-engineered strain that enhances efficacy against GAS by preventing the survival-promoting interactions between the probiotic and pathogenic bacteria. This modified strain, now registered as Bactoblis® EVOL in Italy (EU), holds potential as an effective version to reduce the incidence and severity of GAS infections without the drawbacks of antibiotic therapy.
The primary aim of this clinical trial is to evaluate whether prophylactic use of S. salivarius eK12 can effectively reduce the frequency and severity of strep throat episodes in children. By assessing the efficacy of S. salivarius eK12 supplementation, this study seeks to provide insights into its potential as a non-antibiotic preventive strategy for recurrent strep throat infections in pediatric populations.
Age
3 - 10 years
Sex
ALL
Healthy Volunteers
Yes
Liaquat University of Medical and Health Sciences
Jamshoro, Pakistan
Start Date
December 1, 2025
Primary Completion Date
July 30, 2026
Completion Date
August 31, 2026
Last Updated
January 6, 2026
60
ESTIMATED participants
Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)
DIETARY_SUPPLEMENT
Lead Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
Data Source & Attribution
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