Vaginal MicrobiomeNCT05383326
Longitudinal Analysis of the Vaginal Microbiome
An observational study of Vaginal Microbiome, run by Viome at 1 site in United States.
Trial summary
This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 20 Aug 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: At least 10 women with regular menstrual cycles age 18 or older that meet the inclusion criteria.
Who may be able to join
- Biological sex is female
- Willing to collect own vaginal samples
- Willing to answer health questions
- Experience menstrual cycles regularly (a monthly cycle)
Who cannot join
- Pregnant
- Antibiotic use in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.
Read the detailed description
Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.
- Conditions
- Vaginal Microbiome
- Keywords
- vaginal pH, vaginal microbiome, menstrual cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of vaginal microbial taxonomy
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
Measured: 1 year
Identification of vaginal microbial functions
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start7 Jul 2022
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal 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
- Prospective
- Enrolment
- 29 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
- NCT05383326
- Sponsor's protocol ID
- V174
- Status last verified
- Dec 2023
- First submitted
- 16 May 2022
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of the Vaginal Microbiome
- ClinicalTrials.gov ID
- NCT05383326
- Acronym / sponsor ID
- V174
- Conditions
- Vaginal Microbiome
- Keywords
- vaginal pH, vaginal microbiome, menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 20 May 2022 (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 is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.
Detailed description
Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At least 10 women with regular menstrual cycles age 18 or older that meet the inclusion criteria.
Key inclusion criteria (4 listed)
- Biological sex is female
- Willing to collect own vaginal samples
- Willing to answer health questions
- Experience menstrual cycles regularly (a monthly cycle)
Key exclusion criteria (2 listed)
- Pregnant
- Antibiotic use in the past 3 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
Identification of vaginal microbial taxonomy
Time frame: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
Identification of vaginal microbial functions
Time frame: 1 year
A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions
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 Dec 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 Vaginal 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 4 inclusion and 2 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 Dec 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?
Identification of vaginal microbial taxonomy (time frame: 1 year). The study lists 2 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 12 Dec 2023.