Vaginal Ecosystem and Network in the United States Study

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 89 Years

Healthy Volunteers

Accepted

Interventions

• Vaginal Swab Collection — DIAGNOSTIC_TEST
  Vaginal Swab Collection

Study Details

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.

Key Dates

Start date

May 16, 2024

Status verified

Jun 2025

Primary completion

May 15, 2027

Completion

May 15, 2028

Study Design

Enrollment

3,250 participants (estimated)

Arms

• Arm: Premenopausal Healthy
  Premenopausal Healthy
• Arm: Perimenopausal Healthy
  Perimenopausal Healthy
• Arm: Postmenopausal Healthy
  Postmenopausal Healthy
• Arm: Bacterial Vaginosis
  Bacterial Vaginosis
• Arm: Candidiasis
  Yeast Infections
• Arm: Urinary Tract Infection
  Premenopausal and Postmenopausal Women
• Arm: Genitourinary Syndrome of Menopause
  Vaginal Atrophy
• Arm: Lichen Sclerosus/Planus
  Lichen Sclerosus/Planus
• Arm: Vulvodynia
  Vulvodynia
• Arm: Endometriosis
  Endometriosis
• Arm: Ureaplasma
  Ureaplasma
• Arm: Desquamative Inflammatory Vaginitis (DIV)
  Desquamative Inflammatory Vaginitis (DIV)
• Arm: 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

Primary Outcome Measure

Microbiome Analysis [ Time Frame: Day 1 ]

Locations (20)

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