Vaginal Ecosystem and Network in the United States Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal Swab Collection.
- Who it may be relevant to
- Registry conditions: Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause. Basic parameters: 18 years — 89 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States
Overview
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.
Interventions
- Diagnostic test Vaginal Swab Collection
Vaginal Swab Collection
Primary outcome measures
- Microbiome Analysis [Time frame: Day 1]
Secondary outcome measures (1)
- Registry [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Healthy cis-gender women between ages 18 and 89
Exclusion criteria
- Pregnant or trying to conceive (i.e. IVF, IUI)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 20 centers
- Women's Pelvic Health Center — Fullerton
- Claris Health — Los Angeles
- University of California Los Angeles Department of Radiation Oncology — Los Angeles
- Pelvic Pain Rehab — Pasadena
- Healthy Mothers, Healthy Babies Coalition of Hawaii — Honolulu
- Rachel Rubin MD PLLC — Bethesda
- Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine — Easton
- Empowered Midwifery and Wellness LLC — Alexandria
- … and 12 more centers
Canada · 1 center
- Integrative Naturopathic Medical Centre — Vancouver
Identifiers
NCT: NCT06472765 · CRVA2024