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Effect of a Probiotic Water on Oral Health in Adults

Primary Purpose

Oral Bacteria, Halitosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Streptococcus salivarius DB-B5 - 2 billion CFU/day

Streptococcus salivarius DB-B5 - 10 billion CFU/day

Placebo

About this trial

This is an interventional basic science trial for Oral Bacteria focused on measuring Probiotic, Oral microbiome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
Willingness to use the assigned products according to instructions, attend scheduled appointments, and likelihood of completing the study.
Males and females with reproductive potential agree to use medically acceptable contraception, as determined by the investigator, for the duration of the study and 30 days after study completion and attest to having used it for three months prior to screening.
Females of child-bearing potential agree to submit to a urine pregnancy test at screening and at the end of the study.

Exclusion Criteria:

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.
Regular use of probiotic supplements or regular consumption of probiotic rich foods such as yoghurt or kefir in the past month.
Require antibiotic prophylaxis for dental or any treatment.
Removable or fixed dental appliances (no implants; crowns allowed if subject has at least 20 uncrowned teeth)
Pregnant or planning to become pregnant during the study period, or breastfeeding.
Uses tobacco products (including smokeless, vaping, and nicotine chewing gums/sprays/lozenges).
Chronic or acute illness such as heart disease, diabetes, cancer, autoimmune condition or HIV that could impact outcome of the study in the opinion of the investigator.
Use of a dental product or is on a medication/treatment that could impact outcome of the study in the opinion of the investigator.
Is unwilling or unable to provide informed consent and follow study procedures.
Has participated in any clinical study within 30 days.
Clinical site personnel or relative or partner of clinical site personnel.
Any other condition or situation that may increase the risk associated with study participation or may interfere with the study results in the opinion of the investigator.

Sites / Locations

Salus Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic - low dose

Probiotic - high dose

Placebo

Arm Description

Powdered probiotic with a carrier.

Carrier only.

Outcomes

Primary Outcome Measures

Oral bacteria levels in saliva and plaque

Change in the levels of the following bacteria in the saliva, and in samples of supra- and subgingival plaque: Streptococcus salivarius (total), Streptococcus salivarius DB-B5 (probiotic strain), Streptococcus mutans and Porphyromonas gingivalis.

Oral bacteria levels on the tongue

Change in the levels of the following bacteria in back-of-tongue samples: Tannerella forsythia, Prevotella (total), Streptococcus salivarius (total) and Streptococcus salivarius DB-B5 (probiotic strain).

Oral malodor

Change in OralChroma malodor readings.

Secondary Outcome Measures

Full Information

NCT ID

NCT04473404

First Posted

July 13, 2020

Last Updated

September 2, 2020

Sponsor

Dose Biosystems Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04473404

Brief Title

Effect of a Probiotic Water on Oral Health in Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 20, 2020 (Actual)

Primary Completion Date

August 26, 2020 (Actual)

Study Completion Date

August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dose Biosystems Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Bacteria, Halitosis

Keywords

Probiotic, Oral microbiome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic - low dose

Arm Type

Experimental

Arm Description

Powdered probiotic with a carrier.

Arm Title

Probiotic - high dose

Arm Type

Experimental

Arm Description

Powdered probiotic with a carrier.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Carrier only.

Intervention Type

Dietary Supplement

Intervention Name(s)

Streptococcus salivarius DB-B5 - 2 billion CFU/day

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Streptococcus salivarius DB-B5 - 10 billion CFU/day

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.

Primary Outcome Measure Information:

Title

Oral bacteria levels in saliva and plaque

Description

Time Frame

4 weeks

Title

Oral bacteria levels on the tongue

Description

Time Frame

4 weeks

Title

Oral malodor

Description

Change in OralChroma malodor readings.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Willingness to use the assigned products according to instructions, attend scheduled appointments, and likelihood of completing the study. Males and females with reproductive potential agree to use medically acceptable contraception, as determined by the investigator, for the duration of the study and 30 days after study completion and attest to having used it for three months prior to screening. Females of child-bearing potential agree to submit to a urine pregnancy test at screening and at the end of the study. Exclusion Criteria: 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. Regular use of probiotic supplements or regular consumption of probiotic rich foods such as yoghurt or kefir in the past month. Require antibiotic prophylaxis for dental or any treatment. Removable or fixed dental appliances (no implants; crowns allowed if subject has at least 20 uncrowned teeth) Pregnant or planning to become pregnant during the study period, or breastfeeding. Uses tobacco products (including smokeless, vaping, and nicotine chewing gums/sprays/lozenges). Chronic or acute illness such as heart disease, diabetes, cancer, autoimmune condition or HIV that could impact outcome of the study in the opinion of the investigator. Use of a dental product or is on a medication/treatment that could impact outcome of the study in the opinion of the investigator. Is unwilling or unable to provide informed consent and follow study procedures. Has participated in any clinical study within 30 days. Clinical site personnel or relative or partner of clinical site personnel. Any other condition or situation that may increase the risk associated with study participation or may interfere with the study results in the opinion of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffery L. Milleman, DDS, MPA

Organizational Affiliation

Salus Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Salus Research, Inc.

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46825

Country

United States

12. IPD Sharing Statement

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Effect of a Probiotic Water on Oral Health in Adults

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