Probiotic Lozenges for Oral Hygiene
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new probiotic lozenge made from S. salivarius SALI-10, which may improve oral health by balancing mouth bacteria. The focus is on gingivitis, a common gum disease caused by plaque buildup, leading to inflammation and other oral health issues. Participants will use the lozenge nightly for a week to determine if it reduces harmful bacteria and inflammation. Individuals with healthy gums, who do not smoke, and are fluent in English may be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the chance to be among the first to try this innovative approach to improving oral health.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any current medications, especially anti-inflammatory, antibiotics, or antimicrobial drugs, at least 30 days before joining the study.
What prior data suggests that this lozenge is safe for oral use?
Research shows that the probiotic Streptococcus salivarius SALI-10, currently under testing, is generally safe. Studies on similar types of S. salivarius, such as K12, have found good tolerance among people. These studies did not report any major side effects, suggesting the treatment is safe for oral use. S. salivarius strains are also known to combat harmful bacteria, potentially improving oral health. Although this trial remains in the early stages, evidence from related studies supports the safety of SALI-10 for people.12345
Why do researchers think this study treatment might be promising?
Unlike the standard oral hygiene treatments like toothpaste and mouthwash, which primarily focus on mechanical cleaning and chemical disinfection, Salivarius SALI-10 lozenges work by modifying the oral microbiome. These lozenges introduce beneficial bacteria, specifically Streptococcus salivarius, directly into the mouth to help balance the bacterial environment. Researchers are excited because this approach not only targets harmful bacteria but also boosts beneficial ones, potentially reducing inflammation in a natural and gentle way. Plus, with a convenient lozenge form taken before bed, it offers a simple and innovative method to enhance oral health.
What evidence suggests that this probiotic lozenge is effective for gingivitis?
Research shows that Salivarius SALI-10, which participants in this trial will receive, might help combat the bacteria in the mouth that cause gum diseases like gingivitis. It produces substances that can kill harmful bacteria, including those leading to periodontal diseases. Studies have found that similar types of S. salivarius can increase the amount of beneficial bacteria in the mouth. This increase might help restore balance and reduce swelling. Although most current evidence comes from lab studies, Salivarius SALI-10 shows promising potential to improve oral health.46789
Who Is on the Research Team?
Michael Glogauger, MD
Principal Investigator
Ostia Sciences Inc
Are You a Good Fit for This Trial?
This trial is for adults interested in improving oral hygiene. It's exploring if lozenges can be an effective way to deliver S. salivarius SALI-10 probiotics, which might help with conditions like gingivitis by shifting the balance of bacteria in the mouth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer one lozenge containing S. salivarius SALI-10 each night for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Salivarius SALI-10
Trial Overview
The study is testing the viability of using a lozenge form to administer S. salivarius SALI-10 probiotics as a treatment for gingivitis, which affects many adults worldwide due to plaque accumulation and harmful bacterial growth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This study is an open-label, single-arm, exploratory pilot study to be completed over 7 days with 8-10 participants. Participants will self-administer one lozenge containing S. salivarius SALI-10 (10 billion CFU/lozenge) each night after brushing and before bed. Every participant will be given 7 SALI-10 lozenges. 1. The aim of this study is to determine the short-term ability of the Streptococcus salivarius SALI-10 lozenges delivery system to modify the human oral microbiome composition and Oral Inflammatory Load (OIL). Specifically, we aim to: * Assess the change in salivary levels of periodontal-disease-associated bacteria (e.g., P. gingivalis, T. forsythia, T. denticola, and P. micra). * Determine the change in beneficial bacteria levels (e.g., S. salivarius, S. parasanguinis). * Evaluate the change in Oral Inflammatory Load (OIL) by measuring oral neutrophil counts. 2. To monitor the short-term adherence of the 8-10 participants to the clinical protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ostia Sciences
Lead Sponsor
Citations
Discovery of phosphorylated lantibiotics with proimmune ...
Our data suggest that salivaricin 10 consists of a group of naturally occurring antimicrobial peptides in the oral cavity that can induce strong ...
Researchers discover molecule in the mouth that could ...
“Sali10 kills oral pathogens that cause periodontal diseases as well as many multi-drug resistant respiratory pathogens that cause pneumonia,” ...
A New Frontier in Oral Care: Live Streptococcus salivarius ...
A clinical trial involving healthy adults showed that all doses of the probiotic toothpaste significantly increased S. salivarius M18 levels in saliva, with the ...
Effects of Streptococcus salivarius K12 on Experimental ...
Conclusion: Oral administration of the probiotic S. salivarius K12 may mitigate the alveolar bone resorption and attachment loss of ...
Streptococcus salivarius and Ligilactobacillus ...
This review highlights several basic problems associated with bacterial drug resistance, including the decreasing efficacy of commercially available ...
The Genomic Characteristics of Potential Probiotics
S. salivarius exhibits robust antibacterial activity as a probiotic against various pathogenic bacteria. Safety assessments of S. salivarius K12 for oral ...
Comprehensive safety assessment of the probiotic ...
In this study, we characterize Streptococcus salivarius OSTIA SALI-10, a novel strain isolated from the oral cavity of a healthy human adult and ...
8.
researchgate.net
researchgate.net/publication/395584424_Comprehensive_safety_assessment_of_the_probiotic_Streptococcussalivarius_OSTIA_SALI-10(PDF) Comprehensive safety assessment of the probiotic ...
Comprehensive safety assessment of the probiotic Streptococcussalivarius OSTIA SALI-10 ; in the PATRIC bioinformatics environment (v. · 3.22.0; ( ...
9.
utoronto.scholaris.ca
utoronto.scholaris.ca/bitstreams/939ffdb2-0243-46f8-b08e-a19e3ab4a741/downloadSTREPTOCOCCUS SALIVARIUS SECRETES NOVEL ...
Evaluation of safety and human tolerance of the oral probiotic Streptococcus salivarius K12: a randomized, placebo-controlled, double-blind study. Food and ...
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