NCT05383326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

May 16, 2022

Last Update Submit

December 8, 2023

Conditions

Vaginal Microbiome

Keywords

vaginal pHvaginal microbiomemenstrual cycle

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Antibiotic use in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

Study Officials

  • Momchilo Vuyisich

    Viome

    PRINCIPAL INVESTIGATOR

  • Guruduth Banavar

    Viome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 20, 2022

Study Start

July 7, 2022

Primary Completion

August 20, 2023

Study Completion

August 20, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

US(1)