Trials Today

Vaginal Ecosystem and Network in the United States Study

Purpose

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.

Conditions

Bacterial Vaginosis
Candidiasis
Urinary Tract Infections
Genitourinary Syndrome of Menopause
Lichen Sclerosus
Lichen Planus
Vulvodynia
Endometriosis
Ureaplasma Infections
Cancer
Desquamative Inflammatory Vaginitis

Eligibility

Eligible Ages: Between 18 Years and 89 Years
Eligible Genders: Female
Accepts Healthy Volunteers: Yes

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 Design

Phase
Study Type: Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Cross-Sectional

Arm Groups

Arm	Description	Assigned Intervention
Premenopausal Healthy	Premenopausal Healthy	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Perimenopausal Healthy	Perimenopausal Healthy	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Postmenopausal Healthy	Postmenopausal Healthy	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Bacterial Vaginosis	Bacterial Vaginosis	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Candidiasis	Yeast Infections	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Urinary Tract Infection	Premenopausal and Postmenopausal Women	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Genitourinary Syndrome of Menopause	Vaginal Atrophy	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Lichen Sclerosus/Planus	Lichen Sclerosus/Planus	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Vulvodynia	Vulvodynia	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Endometriosis	Endometriosis	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Ureaplasma	Ureaplasma	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
Desquamative Inflammatory Vaginitis (DIV)	Desquamative Inflammatory Vaginitis (DIV)	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection
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	Diagnostic Test: Vaginal Swab Collection Vaginal Swab Collection

Recruiting Locations

More Details

NCT ID: NCT06472765
Status: Enrolling by invitation
Sponsor: Vaginal Biome Science

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.