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

June 18, 2024 updated by: Vaginal Biome Science

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

Recruiting

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90064
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Healthy Mothers, Healthy Babies Coalition of Hawaii
        • Contact:
    • Minnesota
      • Alexandria, Minnesota, United States, 56308
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • Gary H. Goldman, M.D.
        • Contact:
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27101
    • Ohio
      • Mayfield Heights, Ohio, United States, 44124
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • Haven Center for Sexual Medicine & Vulvovaginal Disorders
        • Contact:
          • Corey Babb, DO
          • Phone Number: 918-705-2200
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Center of the Health
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Heidi Peterson, ND
        • Contact:
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Center for Pelvic Medicine
        • Contact:
          • Susan Kellogg-Spadt, PhD, CRNP
          • Phone Number: 610-525-0541
    • Virginia
      • Virginia Beach, Virginia, United States, 23455
        • Recruiting
        • Hello Climax
        • Contact:
        • Principal Investigator:
          • Mary Ojo-Carons, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Premenopausal Healthy
Perimenopausal Healthy
Postmenopausal Healthy
Bacterial Vaginosis
Candidiasis
Yeast Infections
Urinary Tract Infection
Premenopausal and Postmenopausal Women
Genitourinary Syndrome of Menopause
Vaginal Atrophy
Lichen Sclerosus/Planus
Vulvodynia
Endometriosis
Ureaplasma
Desquamative Inflammatory Vaginitis (DIV)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome Analysis
Time Frame: First (and only) Visit
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.
First (and only) Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry
Time Frame: First (and only) Visit
Data collection for future research
First (and only) Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaginal Biome Science

Investigators

  • Principal Investigator: Corey Babb, DO, Haven Center for Sexual Medicine & Vulvovaginal Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Estimated)

June 25, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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