Effect of a Probiotic Water on Oral Health in Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Halitosis; Oral Bacteria
• Intervention / Treatment: Dietary supplement: Streptococcus salivarius DB-B5 - 2 billion CFU/day; Dietary supplement: Streptococcus salivarius DB-B5 - 10 billion CFU/day; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults, 18 to 65 years of age and in good general health and good oral health (no active or uncontrolled diseases or conditions).
2. Presence of at least 20 natural teeth, excluding third molars.
3. Read and sign the Research Subject Information and Consent Form.
4. 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.
5. Willingness to use the assigned products according to instructions, attend scheduled appointments, and likelihood of completing the study.
6. 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.
7. Females of child-bearing potential agree to submit to a urine pregnancy test at screening and at the end of the study.

Exclusion Criteria:

1. Fewer than 20 natural, uncrowned teeth.
2. Active or chronic dental disease.
3. Self-reported dry mouth (xerostomia) by questionnaire.
4. Have had or used any of the following in the past three months: antibiotic treatment, a dental cleaning, mouthrinse.
5. Regular use of probiotic supplements or regular consumption of probiotic rich foods such as yoghurt or kefir in the past month.
6. Require antibiotic prophylaxis for dental or any treatment.
7. Removable or fixed dental appliances (no implants; crowns allowed if subject has at least 20 uncrowned teeth)
8. Pregnant or planning to become pregnant during the study period, or breastfeeding.
9. Uses tobacco products (including smokeless, vaping, and nicotine chewing gums/sprays/lozenges).
10. 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.
11. Use of a dental product or is on a medication/treatment that could impact outcome of the study in the opinion of the investigator.
12. Is unwilling or unable to provide informed consent and follow study procedures.
13. Has participated in any clinical study within 30 days.
14. Clinical site personnel or relative or partner of clinical site personnel.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic - low dose; Powdered probiotic with a carrier.	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.
Experimental: Probiotic - high dose; Powdered probiotic with a carrier.	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.
Placebo Comparator: Placebo; Carrier only.	Other: Placebo; The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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).	4 weeks
Oral malodor	Change in OralChroma malodor readings.	4 weeks

Collaborators and Investigators

• Sponsor: Dose Biosystems Inc.
• Investigators: Principal Investigator: Jeffery L. Milleman, DDS, MPA, Salus Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Probiotic; Oral microbiome
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: DB001-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No