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ENROLLING BY INVITATION
NCT06472765

Vaginal Ecosystem and Network in the United States Study

Sponsor: Vaginal Biome Science

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 89 Years

Study Type

OBSERVATIONAL

Enrollment

3250

Start Date

2024-05-16

Completion Date

2028-05-15

Last Updated

2025-07-01

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Vaginal Swab Collection

Vaginal Swab Collection

Locations (21)

Women's Pelvic Health Center

Fullerton, California, United States

Claris Health

Los Angeles, California, United States

University of California Los Angeles Department of Radiation Oncology

Los Angeles, California, United States

Pelvic Pain Rehab

Pasadena, California, United States

Healthy Mothers, Healthy Babies Coalition of Hawaii

Honolulu, Hawaii, United States

Rachel Rubin MD PLLC

Bethesda, Maryland, United States

Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine

Easton, Maryland, United States

Empowered Midwifery and Wellness LLC

Alexandria, Minnesota, United States

Xena Health

Henderson, Nevada, United States

Empire OBGYN

Kenmore, New York, United States

Gary H Goldman, MD

New York, New York, United States

Camel City Women's Wellness

Winston-Salem, North Carolina, United States

UH Hospitals

Mayfield Heights, Ohio, United States

Northwest Obstetrics and Gynecology

Oklahoma City, Oklahoma, United States

Haven Center for Sexual Medicine & Vulvovaginal Disorders

Tulsa, Oklahoma, United States

Center of the Health

Corvallis, Oregon, United States

Amber Wellness Group

Portland, Oregon, United States

Center for Pelvic Medicine

Bryn Mawr, Pennsylvania, United States

North Houston Gynecologic Oncology Surgeons, PLLC

Shenandoah, Texas, United States

Hello Climax

Virginia Beach, Virginia, United States

Integrative Naturopathic Medical Centre

Vancouver, British Columbia, Canada