At a glance
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A Short, Open, Phase 0 Study to Demonstrate the Viability of the Lozenge Dosage Form to Deliver SALI-10 Oral Probiotics
In Brief
A clinical study evaluating Salivarius SALI-10 for Delivery Systems and Oral Health. Completed, enrolled 8 participants across 1 site.
Detailed 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 promising 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.
Study Details
Timeline
Arms & Interventions
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, the investigators 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.
Interventions
Lozenges containing live Streptococcus salivarius strain OSTIA SALI-10