Oral MicrobiomeNCT05672953
Biogeography of the Oral Microbiome
An observational study of Oral Microbiome, run by Viome at 1 site in United States.
Trial summary
A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity. 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
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 10 Aug 2021
- Phase
- Observational
- 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
Study population: The study population includes anyone that meets the inclusion criteria and does not have any exclusion criteria.
Who may be able to join
- 18 years old or older
Who cannot join
- Positive SARS-CoV-2 test result, if performed
- Antibiotic use in the previous 30 days
- Mouthwash use in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biogeography of the Oral Microbiome Using Metatranscriptomic Analyses
A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.
Read the detailed description
This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.
- Conditions
- Oral Microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
Species richness in multiple oral locations
Number of species present in different areas swabbed in the oral cavity.
Measured: 3 months
Secondary outcomes (1)
KO richness of multiple oral locations
KO richness of multiple areas swabbed in the oral cavity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start20 May 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MicrobiomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, ViomeGuruduth Banavar, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672953
- Sponsor's protocol ID
- V243
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 5 Jan 2023
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biogeography of the Oral Microbiome Using Metatranscriptomic Analyses
- ClinicalTrials.gov ID
- NCT05672953
- Acronym / sponsor ID
- V243
- Conditions
- Oral Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 5 Jan 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.
A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.
Detailed description
This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes anyone that meets the inclusion criteria and does not have any exclusion criteria.
Key inclusion criteria (1 listed)
- 18 years old or older
Key exclusion criteria (3 listed)
- Positive SARS-CoV-2 test result, if performed
- Antibiotic use in the previous 30 days
- Mouthwash use in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Species richness in multiple oral locations
Time frame: 3 months
Number of species present in different areas swabbed in the oral cavity.
1 secondary outcome
KO richness of multiple oral locations
Time frame: 3 months
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 5 Jan 2023.
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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
Guruduth Banavar principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Microbiome, 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 1 inclusion and 3 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 5 Jan 2023. 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?
Species richness in multiple oral locations (time frame: 3 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 5 Jan 2023.