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临床试验/NCT06231303
NCT06231303尚未招募不适用

Gut Microbiota Dysbiosis in Lupus Nephritis

Hager Zanaty0 个研究点目标入组 60 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Evaluate dysbiosis of some intestinal microbiota in adult patients with lupus nephritis compared to healthy controls.

研究概览

简要总结

Evaluate dysbiosis of some intestinal microbiota in adult patients with lupus nephritis compared to healthy controls.

详细描述

Systemic Lupus Erythematosus (SLE) is an autoimmune disease resulting in multi-organ inflammation with complex clinical manifestation including neuropsychiatric, lupus nephritis..etc. However, the actual cause of SLE is still unknown [1].

Various etiologies have been postulated which can be categorized into genetic and environmental such as age, gender, ultra-violet exposure, dietary intake, alcohol, and lifestyle behavior [2].

Lupus nephritis is one of the most severe manifestations of SLE with high mortality rate and 10% of them eventually develop end-stage renal disease within 5 years after diagnosis [3,4].

There are trillion of microbes inhabited human gut which dominated by 4 phyla; Firmicutes, Bacteroidetes, Proteobacteria and Actinobacteria. In healthy human gut, 98% of gut microbiota is dominated by Bacteroidetes and Firmicutes. Every species of gut microbiota play their own role in modulating immune system. Many factors could alter gut communities such as infant transition, dietary habit, age, gender and antibiotic consumption [5, 6].

Firmicutes responsive in fatty acids and carbohydrates absorption whereas Bacteroidetes correspond to polysaccharides absorption [7].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult male and female patients diagnosed with lupus nephritis. Adult age and sex matched healthy individuals will be included as a control group.
  • Informed consent will be obtained from each study participant.

排除标准

  • Subjects at age<18 years. Diseases affecting the gut microbiota (e.g. chronic diarrhea, Crohn's disease, or ulcerative colitis).
  • Patients on maintenance dialysis, with diabetes or pregnancy, using antibiotics, probiotics, prebiotics, or synbiotics in the previous 4 weeks.
  • Patients with critical condition (hypertension emergency,urgency, acute myocardial infarction or stroke within the last 6 months) and suspected/confirmed renal vascular disease.

结局指标

主要结局

Evaluate dysbiosis of some intestinal microbiota in adult patients with lupus nephritis compared to healthy controls.

时间窗: 2 years

Evaluate the relation of dysbiosis of some intestinal microbiota to the stage of lupus nephritis.

次要结局

未报告次要终点

研究者

发起方
Hager Zanaty
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hager Zanaty

Assistant lecturer of nephrology

Assiut University

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