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

NCT06370208 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Streptococcus Pyogenes Pharyngotonsillitis

Interventions

DIETARY_SUPPLEMENT

Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)

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

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-07-30
Completion
2026-08-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370208 on ClinicalTrials.gov