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临床试验/NCT05132621
NCT05132621Unknown不适用

The Genital Tract Microflora in Women With Systemic Lupus Erythematosus and IgA Nephropathy.

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Differences in microflora composition between groups of study participants

研究概览

简要总结

The study hypothesis:

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a broad spectrum of clinical manifestations. Its mechanisms are not well understood. It is known that its development is influenced by genetic factors and gender. However, it is believed that in some patients with a specific genetic predisposition, certain environmental factors such as chemicals, including drugs and toxins, smoking, or infections may initiate the development of the disease. Of particular importance seem to be infections, which by stimulating the immune system can induce new symptoms or exacerbate existing ones.

For this reason, links between the microbiome and the clinical course of SLE are being sought. Most available studies concern the intestinal microbiome. So far, the relationship between the genital tract microbiota and the clinical picture of SLE has not been documented.

Aim of the study:

This study aims to identify and differentiate the genital tract microbiota of women with a diagnosis of systemic lupus, IgA nephropathy and a control group of healthy women. The results will be correlated with the clinical presentation of these diseases. In addition, the isolated bacterial strains will be secured for further study.

研究设计

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

入排标准

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

入选标准

  • Age >18 years,
  • Confirmed diagnosis of SLE or IgA nephropathy,
  • First half of the menstrual cycle, after the end of bleeding,
  • Signed informed consent to participate in the study.

排除标准

  • Lack of menstruation,
  • Pregnancy,
  • Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
  • Neoplastic disease of the reproductive tract.

结局指标

主要结局

Differences in microflora composition between groups of study participants

时间窗: Two months

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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