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.

Study Overview

• Status: Completed
• Conditions: Vaginal Microbiome

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Viome Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

At least 10 women with regular menstrual cycles age 18 or older that meet the inclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of vaginal microbial taxonomy	A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome taxonomy	1 year
Identification of vaginal microbial functions	A vaginal metatranscriptomic test will be used to analyze the vaginal microbiome functions	1 year

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome; Principal Investigator: Guruduth Banavar, Viome

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: menstrual cycle; vaginal pH; vaginal microbiome
• Other Study ID Numbers: V174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No