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OpenTrials
Completed

NCT Number: NCT05383326

Longitudinal Analysis of the Vaginal Microbiome

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.

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Key information

Conditions

Vaginal Microbiome

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Viome Life Sciences

Bothell, Washington, 98011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of vaginal microbial taxonomy

    Time frame: 1 year

    A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy

  2. Identification of vaginal microbial functions

    Time frame: 1 year

    A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions

Sponsors and collaborators

Lead sponsor

Viome

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2022
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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