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Longitudinal Analysis of the Vaginal Microbiome

NCT ID: NCT05383326

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-07

Study Completion Date

2023-08-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaginal Microbiome

Keywords

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vaginal pH vaginal microbiome menstrual cycle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Viome

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Momchilo Vuyisich

Role: PRINCIPAL_INVESTIGATOR

Viome

Guruduth Banavar

Role: PRINCIPAL_INVESTIGATOR

Viome

Locations

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Viome Life Sciences

Bothell, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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V174

Identifier Type: -

Identifier Source: org_study_id