NCT04473404

Effect of a Probiotic Water on Oral Health in Adults

Evaluation of the Effect of an Oral Probiotic on Oral Bacteria and Malodor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dose Biosystems Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of consuming a probiotic on salivary, plaque, and tongue bacteria, as well as oral malodor (bad breath). Healthy volunteers will consume a probiotic powder, or a placebo powder, that is dissolved in water for 4 weeks.

Detailed description

The oral cavity houses one of the most diverse microbiota in the human body. There are nearly 800 unique oral bacterial species identified with more species expected to be added with further sampling and identification. As with microbiota of other sites in the body, a balanced oral microbiota is essential to maintaining the health of the human host. Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from birth, and remains a predominant member of the commensal microbiota throughout life. The commensal microbiota provides protection against pathogenic species associated with conditions such as dental caries, periodontal disease, and oral malodor (halitosis). This randomized, double-blind, placebo-controlled study is conducted to investigate the effect of a Streptococcus salivarius DB-B5 strain on oral bacteria levels and halitosis. Doses of 2 billion and 10 billion colony forming units (CFU) per day are tested.

Conditions

• Oral Bacteria
• Halitosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Streptococcus salivarius DB-B5 - 2 billion CFU/day	The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 1 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
DIETARY_SUPPLEMENT	Streptococcus salivarius DB-B5 - 10 billion CFU/day	The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
OTHER	Placebo	The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-08-26
• Completion: 2020-08-26
• First posted: 2020-07-16
• Last updated: 2020-09-04

Locations

1 site across 1 country: United States