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