Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12

Strep Throat Clinical Trial

Official title: Study to Evaluate the Safety and Human Tolerance of the Oral Probiotic Streptococcus Salivarius K12: A Randomized, Double-blind Clinical Trial

Status Not yet recruiting

Clinical Trial Summary

Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene.

Clinical Trial Description

Numerous clinical studies have delved into the therapeutic potential of Streptococcus salivarius K12 across a broad spectrum of health conditions including prevention of recurrent upper respiratory tract infection such as such as sore throat, tonsillitis, and pharyngitis, in both adults and pediatrics. However, despite this extensive exploration, only limited clinical trials have explicitly focused on assessing its safety profile and human tolerance. Therefore, the primary objective of the present clinical trial is to bridge this gap in knowledge by meticulously evaluating the safety and tolerance of Streptococcus salivarius K12 in human subjects. By conducting comprehensive assessments and closely monitoring participants' responses, this trial aims to elucidate crucial insights into the safety profile and human tolerance of this probiotic strain. The findings gleaned from this clinical trial will not only enhance our understanding of Streptococcus salivarius K12's safety but also provide invaluable guidance for its future evidence-based therapeutic applications in oral health management and disease prevention. ;

Related Conditions & MeSH terms

• Strep Throat

• NCT number: NCT06380270
• Study type: Interventional
• Source: Liaquat University of Medical & Health Sciences
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: December 31, 2024