跳至主要内容
临床试验/NCT05706922
NCT05706922招募中不适用

Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Bacterial composition of the gut in women with PCOS and control group

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bacterial composition of the gut in women with PCOS and control group

时间窗: 1 week

Bacterial composition in the gut is analysed using 16S rRNA gene sequencing

次要结局

  • To analyse potential metabolic profiles characterizing different phenotypes of PCOS(1 week)
  • Bacterial composition of the vagina in women with PCOS and control group(1 week)
  • Difference in bacterial composition of the vagina and gut in women with PCOS(1 week)
  • Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sam Schoenmakers

Principal Investigator

Erasmus Medical Center

研究点 (1)

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