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Gut- and Vaginal Microbiome Composition in Association With PCOS

Study acronym: GuVaPCOS
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Primary completion date changed from estimate of Jun 2024 to Jul 31, 2024v3
  3. Notable Primary completion date: Nov 2023 to Jun 2024 Start date changed from estimate of Jan 24, 2023 to Nov 16, 2023 · Completion date: Jul 2024 to Dec 2024v2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 24, 2023 to Nov 16, 2023
    • Completion date: Jul 2024 to Dec 2024
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects up to 10% of the reproductive-aged women worldwide. The etiology is still unknown and treatment therefore remains symptomatic. Studies indicate a possible role of the gut microbiome in the pathology of PCOS. PCOS women have a disturbed gut microbiome, with certain species associated with the PCOS characteristics:hyperandrogenism, ovarian dysfunction, obesity, glucose intolerance and insulin resistance. Although differences have been found in gut microbiome composition between PCOS and healthy women, the literature is inconclusive regarding the difference in gut microbiome biodiversity. Studies examining the vaginal microbiome in PCOS women show consistent results with specific species in the vaginal microbiome. However, there are only few studies on the vaginal microbiome in PCOS women and no studies have yet investigated the correlation between sex-specific hormones and PCOS characteristics. More research is needed to understand the function of the microbiome in the pathophysiology of PCOS, so that this can offer perspectives in future therapies.
Trial Details
NCT Number NCT05706922
Lead Sponsor Erasmus Medical Center
Conditions Polycystic Ovary Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov