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Vaginal Ecosystem and Network in the United States Study

NCT06472765 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3250

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Vaginal Swab Collection

Vaginal Swab Collection

Sponsors & Collaborators

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Kimberly Capone, PhD · Vaginal Biome Science

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2027-05-15
Completion
2028-05-15

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06472765 on ClinicalTrials.gov