Vaginal Ecosystem and Network in the United States Study

Last updated: February 10, 2025
Sponsor: Vaginal Biome Science
Overall Status: Active - Enrolling

Phase

N/A

Condition

Fungal Infections

Yeast Infections

Rash

Treatment

Vaginal Swab Collection

Clinical Study ID

NCT06472765
CRVA2024
  • Ages 18-89
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy cis-gender women between ages 18 and 89

Exclusion

Exclusion Criteria:

  • Immunosuppressed or otherwise immunocompromised

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

Study Design

Total Participants: 3250
Treatment Group(s): 1
Primary Treatment: Vaginal Swab Collection
Phase:
Study Start date:
May 16, 2024
Estimated Completion Date:
May 15, 2026

Study 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.

Connect with a study center

  • Claris Health

    Los Angeles, California 90064
    United States

    Site Not Available

  • Healthy Mothers, Healthy Babies Coalition of Hawaii

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Empowered Midwifery and Wellness LLC

    Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Gary H. Goldman, M.D.

    New York, New York 10128
    United States

    Site Not Available

  • Hormone Wellness, MD

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Camel City Women's Wellness

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Camel City Women's Wellness

    Winston-Salem, North Carolina 27101
    United States

    Active - Recruiting

  • UH Hospitals

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Haven Center for Sexual Medicine & Vulvovaginal Disorders

    Tulsa, Oklahoma 74137
    United States

    Active - Recruiting

  • Haven Center for Sexual Medicine & Vulvovaginal Disorders

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Center of the Health

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Heidi Peterson, ND

    Portland, Oregon 97213
    United States

    Site Not Available

  • Center for Pelvic Medicine

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Hello Climax

    Virginia Beach, Virginia 23455
    United States

    Site Not Available

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