Clinical trial NCT06472765: Vaginal Ecosystem and Network in the United States Study
Official title: Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bacterial Vaginosis
Candidiasis
Urinary Tract Infections
Genitourinary Syndrome of Menopause
Lichen Sclerosus
Lichen Planus
Vulvodynia
Endometriosis
Ureaplasma Infections
Cancer
Desquamative Inflammatory Vaginitis
Lead sponsor: Vaginal Biome Science
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 3250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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:

1. Premenopausal Healthy
2. Perimenopausal Healthy
3. Postmenopausal Healthy
4. Bacterial Vaginosis
5. Candidiasis (Yeast Infections)
6. Urinary Tract Infection (premenopausal and postmenopausal)
7. Genitourinary Syndrome of Menopause
8. Lichen Sclerosus/Planus
9. Vulvodynia
10. Endometriosis
11. Ureaplasma
12. Desquamative Inflammatory Vaginitis (DIV)
13. Cancer (various types)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Microbiome Analysis
timeFrame: Day 1
Secondary outcomes:
measure: Registry
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Claris Health
state: California
city: Honolulu
country: United States
facility: Healthy Mothers, Healthy Babies Coalition of Hawaii
state: Hawaii
city: Alexandria
country: United States
facility: Empowered Midwifery and Wellness LLC
state: Minnesota
city: New York
country: United States
facility: Gary H. Goldman, M.D.
state: New York
city: Winston-Salem
country: United States
facility: Camel City Women&#39;s Wellness
state: North Carolina
city: Mayfield Heights
country: United States
facility: UH Hospitals
state: Ohio
city: Tulsa
country: United States
facility: Haven Center for Sexual Medicine &amp; Vulvovaginal Disorders
state: Oklahoma
city: Corvallis
country: United States
facility: Center of the Health
state: Oregon
city: Portland
country: United States
facility: Heidi Peterson, ND
state: Oregon
city: Bryn Mawr
country: United States
facility: Center for Pelvic Medicine
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Hello Climax
state: Virginia
Study officials:
affiliation: Vaginal Biome Science
name: Kimberly Capone, PhD
role: PRINCIPAL_INVESTIGATOR
References: