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Vaginal Ecosystem and Network in the United States Study

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06472765
Acronym
VENUS
Enrollment
3250
Registered
2024-06-25
Start date
2024-05-16
Completion date
2028-05-15
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Cancer, Candidiasis, Desquamative Inflammatory Vaginitis, Endometriosis, Genitourinary Syndrome of Menopause, Lichen Planus, Lichen Sclerosus, Ureaplasma Infections, Urinary Tract Infections, Vulvodynia

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTVaginal Swab Collection

Vaginal Swab Collection

Sponsors

Vaginal Biome Science
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy cis-gender women between ages 18 and 89

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiome AnalysisDay 1To 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

MeasureTime frameDescription
RegistryDay 1Data collection for future research

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026