Clinical Research Directory

Determining the Viability a Lozenge Dosage for Probiotics

Sponsor: Ostia Sciences

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.

Official title: A Short, Open, Phase 0 Study to Demonstrate the Viability of the Lozenge Dosage Form to Deliver SALI-10 Oral Probiotics

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