An observational study in Bacterial Vaginosis, Candidiasis and Urinary Tract Infections, sponsored by Vaginal Biome Science. Enrolling by invitation at 21 sites in 2 countries. Open to female participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Vaginal Biome Science · Observational
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.
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.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's planned enrollment of 3,250 is above the median of 350 across 30 observational studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Vaginal Biome Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study's substantial sample size of 3,250 participants is statistically justified to ensure a diverse and representative sample of the population, providing increased statistical power for detecting variations in the vaginal microbiome. This approach not only allows for a comprehensive understanding of microbiome variability but also ensures the ethical utility of the research, making the findings significantly beneficial for a broad demographic. The following are the subgroups of conditions/individuals that will be sampled, each 250 swabs:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Premenopausal Healthy
Diagnostic Test: Vaginal Swab Collection
Perimenopausal Healthy
Diagnostic Test: Vaginal Swab Collection
Postmenopausal Healthy
Diagnostic Test: Vaginal Swab Collection
Bacterial Vaginosis
Diagnostic Test: Vaginal Swab Collection
Yeast Infections
Diagnostic Test: Vaginal Swab Collection
Premenopausal and Postmenopausal Women
Diagnostic Test: Vaginal Swab Collection
Vaginal Atrophy
Diagnostic Test: Vaginal Swab Collection
Lichen Sclerosus/Planus
Diagnostic Test: Vaginal Swab Collection
Vulvodynia
Diagnostic Test: Vaginal Swab Collection
Endometriosis
Diagnostic Test: Vaginal Swab Collection
Ureaplasma
Diagnostic Test: Vaginal Swab Collection
Desquamative Inflammatory Vaginitis (DIV)
Diagnostic Test: Vaginal Swab Collection
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
Microbiome Analysis
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.
Time frame: Day 1
Registry
Data collection for future research
Time frame: Day 1
Plan to share: Undecided
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Vaginal Biome Science