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RECRUITING
NCT06370208
NA

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

Sponsor: Liaquat University of Medical & Health Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

3 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-01

Completion Date

2026-08-31

Last Updated

2026-01-06

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)

Bactoblis® EVOL: containing one billion CFU of probiotic Streptococcus salivarius eK12

Locations (1)

Liaquat University of Medical and Health Sciences

Jamshoro, Pakistan