Vaginal Ecosystem and Network in the United States Study
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
🗓️ Study Start (Actual) 16 May 2024
🗓️ Primary Completion (Estimated) 15 May 2025
✅ Study Completion (Estimated) 15 May 2026
👥 Enrollment (Estimated) 3250
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States
📍 Honolulu, Hawaii, United States
📍 Alexandria, Minnesota, United States
📍 New York, New York, United States
📍 Raleigh, North Carolina, United States
📍 Winston-Salem, North Carolina, United States
📍 Mayfield Heights, Ohio, United States
📍 Tulsa, Oklahoma, United States
📍 Corvallis, Oregon, United States
📍 Portland, Oregon, United States
📍 Bryn Mawr, Pennsylvania, United States
📍 Virginia Beach, Virginia, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 June 2024
  • First Submitted that Met QC Criteria 18 June 2024
  • First Posted 25 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 June 2024
  • Last Update Posted 25 June 2024
  • Last Verified June 2024