Summary

Eligibility
for females ages 18-89 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Comprehensive Registry and PCR Analysis of the Vaginal Microbiome in Women: Data Collection in Healthy and Diseased States

Details

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.

Keywords

Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Genitourinary Syndrome of Menopause, Lichen Sclerosus, Lichen Planus, Vulvodynia, Endometriosis, Ureaplasma Infections, Cancer, Desquamative Inflammatory Vaginitis, Infections, Communicable Diseases, Vaginitis, Lichen Sclerosus et Atrophicus, Vaginal Swab Collection, Urinary Tract Infection, Lichen Sclerosus/Planus, Ureaplasma, Desquamative Inflammatory Vaginitis (DIV)

Eligibility

You can join if…

Open to females ages 18-89

  • Healthy cis-gender women between ages 18 and 89

You CAN'T join if...

  • Pregnant or trying to conceive (i.e. IVF, IUI)

Locations

  • University of California Los Angeles Department of Radiation Oncology
    Los Angeles California 90095 United States
  • Claris Health
    Los Angeles California 90064 United States
  • Pelvic Pain Rehab
    Pasadena California 91106 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Vaginal Biome Science
ID
NCT06472765
Study Type
Observational [Patient Registry]
Participants
Expecting 3250 study participants
Last Updated