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Longitudinal Analysis of the Vaginal Microbiome

Longitudinal Analysis of the Vaginal Microbiome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05383326
Enrollment
29
Registered
2022-05-20
Start date
2022-07-07
Completion date
2023-08-20
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Microbiome

Keywords

vaginal pH, vaginal microbiome, menstrual cycle

Brief 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. 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.

Interventions

None listed

Sponsors

Viome
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Biological sex is female * Willing to collect own vaginal samples * Willing to answer health questions * Experience menstrual cycles regularly (a monthly cycle)

Exclusion criteria

* Pregnant * Antibiotic use in the past 3 months

Design outcomes

Primary

MeasureTime frameDescription
Identification of vaginal microbial taxonomy1 yearA vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy
Identification of vaginal microbial functions1 yearA vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026