Vaginal Ecosystem and Network in the United States Study

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

• Registration Number: NCT06472765
• Lead Sponsor: Vaginal Biome Science

Brief 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.

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 Timeline

• Study Start: 2024-05-16
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-29
• Last Update Posted: 2025-07-01
• Primary Completion: 2027-05-15
• Study Completion: 2028-05-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 3250

Inclusion Criteria

• Healthy cis-gender women between ages 18 and 89

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiome Analysis	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Registry	Day 1	Data collection for future research

Trial Locations

Locations (21)

Women's Pelvic Health Center; 🇺🇸 Fullerton, California, United States

University of California Los Angeles Department of Radiation Oncology; 🇺🇸 Los Angeles, California, United States

Pelvic Pain Rehab; 🇺🇸 Pasadena, California, United States

Rachel Rubin MD PLLC; 🇺🇸 Bethesda, Maryland, United States

Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine; 🇺🇸 Easton, Maryland, 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

Northwest Obstetrics and Gynecology; 🇺🇸 Oklahoma City, Oklahoma, United States

Amber Wellness Group; 🇺🇸 Portland, Oregon, United States

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