NCT06370208

Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Streptococcus Pyogenes Pharyngotonsillitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)	Bactoblis® EVOL: containing one billion CFU of probiotic Streptococcus salivarius eK12

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-07-30
• Completion: 2026-08-31
• First posted: 2024-04-17
• Last updated: 2026-01-06

Locations

1 site across 1 country: Pakistan