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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premenopausal Healthy | Premenopausal Healthy |
| |
| Perimenopausal Healthy | Perimenopausal Healthy |
| |
| Postmenopausal Healthy | Postmenopausal Healthy |
| |
| Bacterial Vaginosis | Bacterial Vaginosis |
| |
| Candidiasis | Yeast Infections |
| |
| Urinary Tract Infection | Premenopausal and Postmenopausal Women |
| |
| Genitourinary Syndrome of Menopause |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Swab Collection | Diagnostic Test | Vaginal Swab Collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Registry | Data collection for future research | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Cis-gender women
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Capone, PhD | Vaginal Biome Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Pelvic Health Center | Fullerton | California | 92835 | United States | ||
| Claris Health |
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Vaginal swab for Next Generation Sequencing and Polymerase Chain Reaction tests.
Vaginal Atrophy |
|
| Lichen Sclerosus/Planus | Lichen Sclerosus/Planus |
|
| Vulvodynia | Vulvodynia |
|
| Endometriosis | Endometriosis |
|
| Ureaplasma | Ureaplasma |
|
| Desquamative Inflammatory Vaginitis (DIV) | Desquamative Inflammatory Vaginitis (DIV) |
|
| 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 |
|
| Los Angeles |
| California |
| 90064 |
| United States |
| University of California Los Angeles Department of Radiation Oncology | Los Angeles | California | 90095 | United States |
| Pelvic Pain Rehab | Pasadena | California | 91106 | United States |
| Healthy Mothers, Healthy Babies Coalition of Hawaii | Honolulu | Hawaii | 96817 | United States |
| Rachel Rubin MD PLLC | Bethesda | Maryland | 20814 | United States |
| Dr. Christina Enzmann at Easton Advanced Aesthetics and Regenerative Medicine | Easton | Maryland | 21601 | United States |
| Empowered Midwifery and Wellness LLC | Alexandria | Minnesota | 56308 | United States |
| Xena Health | Henderson | Nevada | 89074 | United States |
| Empire OBGYN | Kenmore | New York | 14217 | United States |
| Gary H Goldman, MD | New York | New York | 10128 | United States |
| Camel City Women's Wellness | Winston-Salem | North Carolina | 27101 | United States |
| UH Hospitals | Mayfield Heights | Ohio | 44124 | United States |
| Northwest Obstetrics and Gynecology | Oklahoma City | Oklahoma | 73112 | United States |
| Haven Center for Sexual Medicine & Vulvovaginal Disorders | Tulsa | Oklahoma | 74137 | United States |
| Center of the Health | Corvallis | Oregon | 97330 | United States |
| Amber Wellness Group | Portland | Oregon | 97213 | United States |
| Center for Pelvic Medicine | Bryn Mawr | Pennsylvania | 19010 | United States |
| North Houston Gynecologic Oncology Surgeons, PLLC | Shenandoah | Texas | 77384 | United States |
| Hello Climax | Virginia Beach | Virginia | 23455 | United States |
| Integrative Naturopathic Medical Centre | Vancouver | British Columbia | V6H 3X8 | Canada |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002177 | Candidiasis |
| D014552 | Urinary Tract Infections |
| D018459 | Lichen Sclerosus et Atrophicus |
| D008010 | Lichen Planus |
| D056650 | Vulvodynia |
| D004715 | Endometriosis |
| D016869 | Ureaplasma Infections |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009181 | Mycoses |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014845 | Vulvar Diseases |
| D009180 | Mycoplasmatales Infections |
| D016905 | Gram-Negative Bacterial Infections |
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