Oral Microbiome HealthNCT05972330
Efficacy of VRx MyBiotics Oral Lozenges
A study testing VRx MyBiotics Oral Lozenges in people with Oral Microbiome Health, run by Viome at 1 site in United States.
Trial summary
This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Microbiome Health
- What is being tested?
- VRx MyBiotics Oral Lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 26 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any person with a US address that is 18 years old or older
- Able to speak and read English
- Willing and able to follow the trial instructions, as described in the recruitment letter
- Signed and dated informed consent prior to any trial-specific procedures.
Who cannot join
- Systemic antibiotic treatment 30 days prior to enrollment or during the trial
- Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
- Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
- Allergy to tapioca, peppermint, or sweet potato
- Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
- No dental procedures 30 days prior to enrollment or during the trial (regular cleanings, bone grafts, dental implants, etc)
Show all 12Show fewer
- Pregnancy or planned pregnancy
- Currently have cancer or undergoing cancer therapy
- Dentures
- Fewer than 20 teeth
- Use of at home teeth whitening products 30 days prior to enrollment or during the trial
- Start new medications or supplements during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome
This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.
Read the detailed description
This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.
- Conditions
- Oral Microbiome Health
- Being tested
- VRx MyBiotics Oral Lozenges
- Keywords
- oral health, oral lozenge, oral microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRx MyBiotics Oral LozengesDietary supplement
VRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics.
| Study group | Role | What they receive |
|---|---|---|
| VRx MyBiotics Oral Lozenges | Experimental | Participants will receive a 30 day supply of their personalized oral biotic lozenges. Receives: Dietary Supplement: VRx MyBiotics Oral Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viome Oral Health Score
Increase in oral health score as measured by Viome's Oral Health Score.
Measured: ~ 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start26 Jun 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Microbiome HealthStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972330
- Sponsor's protocol ID
- V308
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome
- ClinicalTrials.gov ID
- NCT05972330
- Acronym / sponsor ID
- V308
- Conditions
- Oral Microbiome Health
- Keywords
- oral health, oral lozenge, oral microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 2 Aug 2023 (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.
This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.
Detailed description
This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
| Arm | Type | Receives |
|---|---|---|
| VRx MyBiotics Oral Lozenges | Experimental | Dietary Supplement: VRx MyBiotics Oral LozengesParticipants will receive a 30 day supply of their personalized oral biotic lozenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any person with a US address that is 18 years old or older
- Able to speak and read English
- Willing and able to follow the trial instructions, as described in the recruitment letter
- Signed and dated informed consent prior to any trial-specific procedures.
Key exclusion criteria (12 listed)
- Systemic antibiotic treatment 30 days prior to enrollment or during the trial
- Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
- Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
- Allergy to tapioca, peppermint, or sweet potato
- Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
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 |
|---|---|---|
| VRx MyBiotics Oral LozengesVRx MyBiotics Oral Lozenges are composed of prebiotics, probiotics, and postbiotics. | Dietary supplement | VRx MyBiotics Oral Lozenges |
Primary outcome
Viome Oral Health Score
Time frame: ~ 4 months
Increase in oral health score as measured by Viome's Oral Health Score.
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 12 Feb 2024.
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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.
Momchilo Vuyisich principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRx MyBiotics Oral Lozenges in people with Oral Microbiome Health, run by Viome 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 4 inclusion and 12 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 12 Feb 2024. 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. 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?
Viome Oral Health Score (time frame: ~ 4 months). 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 12 Feb 2024.