Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Streptococcus salivarius DB-B5 - 2 billion CFU/day

+ Streptococcus salivarius DB-B5 - 10 billion CFU/day

+ Placebo

Dietary SupplementOther
Who is being recruted

Halitosis+1

+ Signs and Symptoms

+ Signs and Symptoms, Digestive

From 18 to 65 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorDose Biosystems Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 20, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of the Effect of an Oral Probiotic on Oral Bacteria and Malodor
NCT04473404
Principal SponsorDose Biosystems Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HalitosisSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

7 inclusion criteria required to participate
Adults, 18 to 65 years of age and in good general health and good oral health (no active or uncontrolled diseases or conditions).

Presence of at least 20 natural teeth, excluding third molars.

Read and sign the Research Subject Information and Consent Form.

Have an OralChroma reading ≥ 125 ppb hydrogen sulfide (H2S) gas, volatile sulfur compound (VSC) (at least 8-12 hours after eating or drinking or oral hygiene) at Baseline.

Show More Criteria

15 exclusion criteria prevent from participating
Fewer than 20 natural, uncrowned teeth.

Active or chronic dental disease.

Self-reported dry mouth (xerostomia) by questionnaire.

Have had or used any of the following in the past three months: antibiotic treatment, a dental cleaning, mouthrinse.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Powdered probiotic with a carrier.

Group II

Experimental
Powdered probiotic with a carrier.

Group III

Placebo
Carrier only.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Salus Research, Inc.

Fort Wayne, United StatesOpen Salus Research, Inc. in Google Maps
CompletedOne Study Center