Effect of a Probiotic Water on Oral Health in Adults

NCT04473404 | Completed

• 1 other identifier: DB001-2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Bacteria; Halitosis

Keywords

Probiotic; Oral microbiome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Probiotic - low dose

EXPERIMENTAL

Powdered probiotic with a carrier.

Dietary Supplement: Streptococcus salivarius DB-B5 - 2 billion CFU/day

Probiotic - high dose

EXPERIMENTAL

Powdered probiotic with a carrier.

Dietary Supplement: Streptococcus salivarius DB-B5 - 10 billion CFU/day

Placebo

PLACEBO COMPARATOR

Carrier only.

Other: Placebo

Interventions

Streptococcus salivarius DB-B5 - 2 billion CFU/day DIETARY_SUPPLEMENT

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.

Probiotic - low dose

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

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.

Probiotic - high dose

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dose Biosystems Inc.: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffery L. Milleman, DDS, MPA

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: July 20, 2020
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-07

Locations

US (1)