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NCT06370208

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

Recruiting now NA Last updated 6 January 2026
What this trial tests

NA trial testing Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12) in Streptococcus Pyogenes Pharyngotonsillitis in 60 participants. Currently enrolling.

Timeline
1 December 2025
Primary endpoint
30 July 2026
31 August 2026

Quick facts

Lead sponsorLiaquat University of Medical & Health Sciences
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment60
Start date1 December 2025
Primary completion30 July 2026
Estimated completion31 August 2026
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

Liaquat University of Medical & Health Sciences

Who can join

Adults 3 to 10, any sex, with Streptococcus Pyogenes Pharyngotonsillitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pediatric acute-onset neuropsychiatric syndromes and the gut-oral-brain axis: a narrative review of emerging microbiome-immune interactions and therapeutic perspectives.
    Matera M, Biagioli V, Illiceto MT, Palazzi CM, et al · · 2025 · PMID 41394880 · DOI 10.3389/fimmu.2025.1726630

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