Probiotic Lozenges for Oral Hygiene

Overseen By Mark Kwiecinski, P.Eng, M.Sc

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Ostia Sciences

Must not be taking: Anti-inflammatories, Antibiotics, Antimicrobials, others

Disqualifiers: Orthodontic bands, Dentures, Periodontal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Gingivitis is an oral disease condition affecting 50% to 90% of adults globally. Gingivitis is a reversible inflammatory condition caused by the accumulation of dental plaque and the associated disruption of the host-microbial homeostasis. During gingivitis, the microbial community shifts from gram-positive health-associated bacteria, to gram-negative disease associated species. This shift triggers inflammatory responses, leading to tissue damage and, in some cases, progression to periodontitis. A promise area of oral health is treating the oral cavity with gram-positive probiotics to improve oral health. One promising candidate is S. salivarius SALI-10. Typically oral probiotics are dosed to the oral cavity using lozenges. This study is a pre-clinical Phase 0 trial to determine is a lozenge is a viable dosage form for the delivery of salivarius SALI-10 oral probiotics.

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

Non-smokers

In good general health, ASA I

Fluent in English

Exclusion Criteria

Participation in any other clinical study or test panel within one month before entering the study

Use of tobacco products

Presence of orthodontic bands

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Telephone pre-screening

Treatment

Participants self-administer one lozenge containing S. salivarius SALI-10 each night for 7 days

1 week

No in-person visits; home administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Email confirmation and feedback collection

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?

Group I: Receives Probiotic Lozenge Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Ostia Sciences

Lead Sponsor

Trials

1

Recruited

10+