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NCT05383326 Clinical Trial

Longitudinal Analysis of the Vaginal Microbiome

Vaginal Microbiome Clinical Trial

Official title:
Longitudinal Analysis of the Vaginal Microbiome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05383326
Other study ID # V174
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 7, 2022
Est. completion date August 20, 2023

Study information
Verified date December 2023
Source Viome
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. This study is direct to participant and will NOT utilize clinical sites.

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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date August 20, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Viome Life Sciences Bothell Washington

Sponsors (1)
Lead Sponsor Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of vaginal microbial taxonomy A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy 1 year
Primary Identification of vaginal microbial functions A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions 1 year
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