Vaginal Ecosystem and Network in the United States Study

The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. Specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Vaginal Atrophy, and others. By employing PCR testing and the outcomes of next-generation sequencing (NGS) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. This nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Cancer Candidiasis Desquamative Inflammatory Vaginitis Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genitourinary Syndrome of Menopause Gram-Negative Bacterial Infections Infections Lichen Planus Lichen Sclerosus Lichen Sclerosus et Atrophicus Lichenoid Eruptions Male Urogenital Diseases Mycoplasmatales Infections Mycoses Neoplasms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Ureaplasma Infections Urinary Tract Infections Urogenital Diseases Urologic Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvodynia

Age range

18 year–89 year

Sex eligibility

Female

Study type

Observational

Primary location

Integrative Naturopathic Medical Centre, Vancouver, British Columbia, Canada

About this study

This study protocol is developed to analyze the vaginal microbiome of women using a 56-panel PCR test and NGS test. The aim is to collect vaginal swab samples from a wide range of participants, including both healthy individuals and those with diagnosed gynecological conditions, to identify different microbiome profiles.

A key aspect of this study is the creation of a registry that will compile the data obtained from the PCR/NGS test results and participant information. This registry will serve as a valuable resource for ongoing research and will support the development of personalized approaches in women's health care. By systematically collecting and analyzing data, the registry will facilitate a better understanding of the vaginal microbiome's role in health and disease, aiding in the advancement of diagnostic and therapeutic strategies.

Additionally, the registry will provide a foundation for future studies, allowing for the exploration of long-term trends and relationships within the vaginal microbiome. This could lead to new insights into how the microbiome influences gynecological health and the development of targeted treatments. The combination of validating a precise diagnostic tool and establishing a comprehensive registry is aimed at enhancing patient care and supporting the broader research community in women's health.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy cis-gender women between ages 18 and 89

Exclusion criteria

Pregnant or trying to conceive (i.e. IVF, IUI)

Treatment and study plan

Vaginal Swab Collection

Diagnostic Test

Vaginal Swab Collection

Primary outcomes

Microbiome Analysis

Time frame: Day 1

To analyze the vaginal microbiome in patients with diverse vaginal health conditions using next-generation sequencing (NGS) and a 56-panel PCR test to understand microbial diversity and implications for disease management.

Secondary outcomes

Registry

Time frame: Day 1

Data collection for future research

Sponsors and collaborators

Lead sponsor

Vaginal Biome Science

Other

Registry information

Official study title

Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States

Acronym: VENUS

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2028
First posted: Jun 25, 2024
Registry last updated: Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting