NCT06380270

Evaluation of Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius eK12

Study to Evaluate the Safety and Human Tolerance of the Oral Probiotic Streptococcus Salivarius eK12: A Randomized, Double-blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The human oral cavity contains a diverse community of microorganisms essential for oral and overall health. Streptococcus salivarius K12 (eK12) has emerged as a promising oral probiotic due to its natural colonization of the throat and its ability to inhibit pathogens such as Streptococcus pyogenes, a major cause of streptococcal pharyngitis. It supports oral hygiene by producing antimicrobial substances like salivaricins and inhibiting odor-causing bacteria. The engineered eK12 variant (Bactoblis® Evol) has been developed to overcome inactivation by GAS-secreted protease SpeB, thereby enhancing its prophylactic potential against Group A Streptococcus (GAS) colonization. This clinical study includes a randomized, double-blind, placebo-controlled trial in Pakistan to evaluate the safety and human tolerance of eK12 in healthy adults. To enhance generalizability, an additional open-label cohort of healthy adults in Italy will receive eK12 without a control group.

Detailed description

The aim of the present clinical study is to evaluate the safety and tolerability of Streptococcus salivarius eK12 in healthy adults. The study consists of a randomized, double-blind, placebo-controlled arm in Pakistan involving 29 participants (allocated 1:1 to eK12 or placebo). In addition, an open-label cohort of 20 healthy adults will be enrolled in Italy, all of whom will receive eK12, to assess tolerability in a separate population without a control group. This complementary cohort is included to enhance the generalizability of the findings across different populations and to obtain supportive safety data in a real-world setting where the product (commercially available in the EU as Bactoblis® Evol) is already in use. Through comprehensive assessments and close monitoring of participants, this study will provide critical insights into the safety profile and human tolerance of the probiotic-modified strain. The findings will contribute to the growing body of knowledge needed to support its use in oral health management.

Conditions

• Safety
• Tolerability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral probiotic Streptococcus salivarius eK12	Bactoblis® EVOL (containing 10 billion CFU of S. salivarius eK12)
OTHER	Placebo	Orally dissolving placebo tablets

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2024-04-23
• Last updated: 2025-09-05

Locations

1 site across 1 country: Pakistan