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Longitudinal Analysis of the Vaginal Microbiome

Sponsor
Viome (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05383326
Collaborator
(none)
10
Enrollment
1
Location
10.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Analysis of the Vaginal Microbiome
    Actual Study Start Date :
    Jul 7, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Identification of vaginal microbial taxonomy [1 year]

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

    2. Identification of vaginal microbial functions [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Viome Life Sciences Bothell Washington United States 98011

    Sponsors and Collaborators

    • Viome

    Investigators

    • Principal Investigator: Momchilo Vuyisich, Viome
    • Principal Investigator: Guruduth Banavar, Viome

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Viome
    ClinicalTrials.gov Identifier:
    NCT05383326
    Other Study ID Numbers:
    • V174
    First Posted:
    May 20, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Viome
    vaginal pH
    vaginal microbiome
    menstrual cycle

    Study Results

    No Results Posted as of Aug 4, 2022