Determining the Viability a Lozenge Dosage for Probiotics

NCT06819761 | Not Yet Recruiting Early Phase 1

• 1 other identifier: OstiaPhase0_2025_02Feb_04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delivery Systems; Oral Health

Keywords

Probiotics; Oral cavity; Lozenge; Dosage Forms

Outcome Measures

Primary Outcomes (1)

• Changes in microbiome composition in the oral cavity

  * 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).

  From enrollment to the end of treatment at 7 days

Secondary Outcomes (1)

• Oral Inflammatory Load

  From enrollment to the end of treatment at 7 days.

Study Arms (1)

Receives Probiotic Lozenge

EXPERIMENTAL

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.

Dietary Supplement: Salivarius SALI-10

Interventions

Salivarius SALI-10 DIETARY_SUPPLEMENT

Lozenge with 10B CFU (Colony Forming Units)

Receives Probiotic Lozenge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers aged 18-70 years
• In good general health, ASA I
• Non-smokers
• Fluent in English

You may not qualify if:

• Presence of orthodontic bands.
• Presence of partial removal dentures.
• Dental pain at time of screening.
• History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
• Participation in any other clinical study or test panel within one month before entering the study.
• Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
• History of periodontal disease.
• History of systemic inflammatory or immune conditions
• Pregnant or nursing women.
• Use of tobacco products.
• Long-term antibiotic or anti-inflammatory therapy.
• Medical condition or any current usage of medication that the investigator considers may compromise the subject's safety as well as the quality of the study results;
• Use of any concomitant medication.

Sponsors & Collaborators

• Ostia Sciences: lead

Study Sites (1)

Ostia Sciences Inc

Toronto, Ontario, M5G 1G6, Canada

Location

Related Publications (10)

• Wellappuli NC, Fine N, Lawrence HP, Goldberg M, Tenenbaum HC, Glogauer M. Oral and Blood Neutrophil Activation States during Experimental Gingivitis. JDR Clin Trans Res. 2018 Jan;3(1):65-75. doi: 10.1177/2380084417742120. Epub 2017 Nov 20.

  PMID: 30938653 BACKGROUND

• van der Weijden F, Slot DE. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000. 2011 Feb;55(1):104-23. doi: 10.1111/j.1600-0757.2009.00337.x. No abstract available.

  PMID: 21134231 BACKGROUND

• LOE H, THEILADE E, JENSEN SB. EXPERIMENTAL GINGIVITIS IN MAN. J Periodontol (1930). 1965 May-Jun;36:177-87. doi: 10.1902/jop.1965.36.3.177. No abstract available.

  PMID: 14296927 BACKGROUND

• Kerns KA, Bamashmous S, Hendrickson EL, Kotsakis GA, Leroux BG, Daubert DD, Roberts FA, Chen D, Trivedi HM, Darveau RP, McLean JS. Localized microbially induced inflammation influences distant healthy tissues in the human oral cavity. Proc Natl Acad Sci U S A. 2023 Oct 10;120(41):e2306020120. doi: 10.1073/pnas.2306020120. Epub 2023 Oct 2.

  PMID: 37782795 BACKGROUND

• Gunsolley JC. A meta-analysis of six-month studies of antiplaque and antigingivitis agents. J Am Dent Assoc. 2006 Dec;137(12):1649-57. doi: 10.14219/jada.archive.2006.0110.

  PMID: 17138709 BACKGROUND

• Gallagher H, Ramsay SC, Barnes J, Maggs J, Cassidy N, Ketheesan N. Neutrophil labeling with [(99m)Tc]-technetium stannous colloid is complement receptor 3-mediated and increases the neutrophil priming response to lipopolysaccharide. Nucl Med Biol. 2006 Apr;33(3):433-9. doi: 10.1016/j.nucmedbio.2005.12.014. Epub 2006 Mar 9.

  PMID: 16631093 BACKGROUND

• Berezow AB, Darveau RP. Microbial shift and periodontitis. Periodontol 2000. 2011 Feb;55(1):36-47. doi: 10.1111/j.1600-0757.2010.00350.x. No abstract available.

  PMID: 21134227 BACKGROUND

• Barbour A, Wescombe P, Smith L. Evolution of Lantibiotic Salivaricins: New Weapons to Fight Infectious Diseases. Trends Microbiol. 2020 Jul;28(7):578-593. doi: 10.1016/j.tim.2020.03.001. Epub 2020 Apr 6.

  PMID: 32544444 BACKGROUND

• Barbour A, Philip K. Variable characteristics of bacteriocin-producing Streptococcus salivarius strains isolated from Malaysian subjects. PLoS One. 2014 Jun 18;9(6):e100541. doi: 10.1371/journal.pone.0100541. eCollection 2014.

  PMID: 24941127 BACKGROUND

• Albandar JM, Rams TE. Global epidemiology of periodontal diseases: an overview. Periodontol 2000. 2002;29:7-10. doi: 10.1034/j.1600-0757.2002.290101.x. No abstract available.

  PMID: 12102700 BACKGROUND

Study Officials

• Michael Glogauger, MD

  Ostia Sciences Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelahhad Barbour, Ph.D

CONTACT

(647) 643-7547; contact@ostia-sciences.com

Mark Kwiecinski, P.Eng, M.Sc

CONTACT

613-513-4413; Mark@PMKengineering.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, single-arm, exploratory pilot study to be completed over 7 days with 8-10 participants.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 11, 2025
• Study Start: March 1, 2025
• Primary Completion: March 15, 2025
• Study Completion: March 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)