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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer; Candidiasis; Endometriosis; Urinary Tract Infections; Lichen Planus; Lichen Sclerosus; Bacterial Vaginosis; Vulvodynia; Genitourinary Syndrome of Menopause; Desquamative Inflammatory Vaginitis; Ureaplasma Infections
• Intervention / Treatment: Diagnostic test: Vaginal Swab Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 3250

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3X8
      • Integrative Naturopathic Medical Centre
• United States
  • California
    • Fullerton, California, United States, 92835
      • Women's Pelvic Health Center
    • Los Angeles, California, United States, 90064
      • Claris Health
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Department of Radiation Oncology
    • Pasadena, California, United States, 91106
      • Pelvic Pain Rehab
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Healthy Mothers, Healthy Babies Coalition of Hawaii
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Rachel Rubin MD PLLC
    • Easton, Maryland, United States, 21601
      • Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Empowered Midwifery and Wellness LLC
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Xena Health
  • New York
    • Kenmore, New York, United States, 14217
      • Empire OBGYN
    • New York, New York, United States, 10128
      • Gary H Goldman, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Camel City Women's Wellness
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • UH Hospitals
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Northwest Obstetrics and Gynecology
    • Tulsa, Oklahoma, United States, 74137
      • Haven Center for Sexual Medicine & Vulvovaginal Disorders
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Center of the Health
    • Portland, Oregon, United States, 97213
      • Amber Wellness Group
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Center for Pelvic Medicine
  • Texas
    • Shenandoah, Texas, United States, 77384
      • North Houston Gynecologic Oncology Surgeons, PLLC
  • Virginia
    • Virginia Beach, Virginia, United States, 23455
      • Hello Climax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study's substantial sample size of 3,250 participants is statistically justified to ensure a diverse and representative sample of the population, providing increased statistical power for detecting variations in the vaginal microbiome. This approach not only allows for a comprehensive understanding of microbiome variability but also ensures the ethical utility of the research, making the findings significantly beneficial for a broad demographic. The following are the subgroups of conditions/individuals that will be sampled, each 250 swabs:

1. Premenopausal Healthy
2. Perimenopausal Healthy
3. Postmenopausal Healthy
4. Bacterial Vaginosis
5. Candidiasis (Yeast Infections)
6. Urinary Tract Infection (premenopausal and postmenopausal)
7. Genitourinary Syndrome of Menopause
8. Lichen Sclerosus/Planus
9. Vulvodynia
10. Endometriosis
11. Ureaplasma
12. Desquamative Inflammatory Vaginitis (DIV)
13. Cancer (various types)

Description

Inclusion Criteria:

• Healthy cis-gender women between ages 18 and 89

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Premenopausal Healthy	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Perimenopausal Healthy	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Postmenopausal Healthy	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Bacterial Vaginosis	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Candidiasis; Yeast Infections	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Urinary Tract Infection; Premenopausal and Postmenopausal Women	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Genitourinary Syndrome of Menopause; Vaginal Atrophy	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Lichen Sclerosus/Planus	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Vulvodynia	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Endometriosis	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Ureaplasma	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Desquamative Inflammatory Vaginitis (DIV)	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection
Cancer; 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	Diagnostic test: Vaginal Swab Collection; Vaginal Swab Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome Analysis	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registry	Data collection for future research	Day 1

Collaborators and Investigators

• Sponsor: Vaginal Biome Science
• Investigators: Principal Investigator: Kimberly Capone, PhD, Vaginal Biome Science

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Genital Diseases, Female; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Vulvar Diseases; Mycoplasmatales Infections; Mycoses; Vaginal Diseases; Lichen Planus; Infections; Communicable Diseases; Urinary Tract Infections; Endometriosis; Lichen Sclerosus et Atrophicus; Vulvodynia; Vaginosis, Bacterial; Candidiasis; Vaginitis; Ureaplasma Infections
• Other Study ID Numbers: CRVA2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No