Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380270
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-14
Brief Title:
Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12
Sponsor:
Liaquat University of Medical Health Sciences
Organization:
Liaquat University of Medical Health Sciences
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 2740-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
Detailed 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 K12s safety but also provide invaluable guidance for its future evidence-based therapeutic applications in oral health management and disease prevention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None