Vaginal Ecosystem and Network in the United States Study (VENUS)

Vaginal Biome Science

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06472765

CRVA2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,250 estimated patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy cis-gender women between ages 18 and 89

Exclusion criteria

• Immunosuppressed or otherwise immunocompromised
• Pregnant or trying to conceive (i.e. IVF, IUI)

Trial design

3,250 participants in 13 patient groups

Premenopausal Healthy

Description:

Premenopausal Healthy

Perimenopausal Healthy

Description:

Perimenopausal Healthy

Postmenopausal Healthy

Description:

Postmenopausal Healthy

Bacterial Vaginosis

Description:

Bacterial Vaginosis

Candidiasis

Description:

Yeast Infections

Urinary Tract Infection

Description:

Premenopausal and Postmenopausal Women

Genitourinary Syndrome of Menopause

Description:

Vaginal Atrophy

Lichen Sclerosus/Planus

Description:

Lichen Sclerosus/Planus

Vulvodynia

Description:

Vulvodynia

Endometriosis

Description:

Endometriosis

Ureaplasma

Description:

Ureaplasma

Desquamative Inflammatory Vaginitis (DIV)

Description:

Desquamative Inflammatory Vaginitis (DIV)

Cancer

Description:

Group 1: Breast cancer patients diagnosed at stages 1-3, post-menopausal (due to surgical, chemical reasons, or age-related natural processes), and currently receiving anti-estrogen treatment for a minimum of 90 days. Group 2: Breast cancer patients diagnosed at stages 1-3, pre-menopausal, and undergoing anti-estrogen endocrine therapy for at least 90 days. Group 3: Participants diagnosed with any type of cancer at stages 1-3, not receiving anti-estrogen therapy, but have been using vaginal estrogen, prasterone, or DHEA for 90 days or more. Should not be on systemic hormone replacement therapy (estrogen with or without progesterone). Group 4: Diagnosed with any type of cancer at stages 1-3, and should not be receiving any anti-estrogen therapy or using vaginal estrogen, prasterone, or DHEA. These individuals must not be on systemic hormone replacement therapy. Group 5: Participants diagnosed at stage 4