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NCT06370208
Prophylactic Effect of Probiotic Streptococcus Salivarius eK12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics
NA trial testing Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12) in Streptococcus Pyogenes Pharyngotonsillitis in 60 participants. Currently enrolling.
30 July 2026
Quick facts
| Lead sponsor | Liaquat University of Medical & Health Sciences |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 December 2025 |
| Primary completion | 30 July 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Probiotic Bactoblis® EVOL (Streptococcus salivarius eK12)
Conditions studied
- Streptococcus Pyogenes Pharyngotonsillitis — all drugs for Streptococcus Pyogenes Pharyngotonsillitis →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06370208
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06370208 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Liaquat University of Medical & Health Sciences
- Last refreshed: 6 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06370208.
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