Oral BacteriaNCT04473404
Effect of a Probiotic Water on Oral Health in Adults
A study testing Streptococcus salivarius DB-B5 - 2 billion CFU/day and Streptococcus salivarius DB-B5 - 10 billion CFU/day in people with Oral Bacteria and Halitosis, run by Dose Biosystems Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Bacteria, Halitosis
- What is being tested?
- Streptococcus salivarius DB-B5 - 2 billion CFU/day and Streptococcus salivarius DB-B5 - 10 billion CFU/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Streptococcus salivarius DB-B5 - 2 billion CFU/day, Streptococcus salivarius DB-B5 - 10 billion CFU/day, Placebo
- Keywords
- Probiotic, Oral microbiome
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius DB-B5 - 2 billion CFU/dayDietary 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.
Streptococcus salivarius DB-B5 - 10 billion CFU/dayDietary 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.
PlaceboOther
The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic - low dose | Experimental | Powdered probiotic with a carrier. Receives: Dietary Supplement: Streptococcus salivarius DB-B5 - 2 billion CFU/day |
| Probiotic - high dose | Experimental | Powdered probiotic with a carrier. Receives: Dietary Supplement: Streptococcus salivarius DB-B5 - 10 billion CFU/day |
| Placebo | Placebo comparator | Carrier only. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 4 weeks
Oral malodor
Change in OralChroma malodor readings.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start20 Jul 2020
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral BacteriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dose Biosystems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L. Milleman, DDS, MPA, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473404
- Sponsor's protocol ID
- DB001-2020
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an Oral Probiotic on Oral Bacteria and Malodor
- ClinicalTrials.gov ID
- NCT04473404
- Acronym / sponsor ID
- DB001-2020
- Conditions
- Oral Bacteria, Halitosis
- Keywords
- Probiotic, Oral microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dose Biosystems Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic - low dose | Experimental | Dietary Supplement: Streptococcus salivarius DB-B5 - 2 billion CFU/dayPowdered probiotic with a carrier. |
| Probiotic - high dose | Experimental | Dietary Supplement: Streptococcus salivarius DB-B5 - 10 billion CFU/dayPowdered probiotic with a carrier. |
| Placebo | Placebo comparator | Other: PlaceboCarrier only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streptococcus salivarius DB-B5 - 2 billion CFU/dayThe 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 | Probiotic - low dose |
| Streptococcus salivarius DB-B5 - 10 billion CFU/dayThe participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks. | Dietary supplement | Probiotic - high dose |
| PlaceboThe participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks. | Other | Placebo |
Primary outcome
Oral bacteria levels in saliva and plaque
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
Change in OralChroma malodor readings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery L. Milleman, DDS, MPA principal investigator
Salus Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus salivarius DB-B5 - 2 billion CFU/day and Streptococcus salivarius DB-B5 - 10 billion CFU/day in people with Oral Bacteria and Halitosis, run by Dose Biosystems Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral bacteria levels in saliva and plaque (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.