跳至主要内容
临床试验/NCT07307482
NCT07307482尚未招募不适用

Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism

Wenxia Jiang0 个研究点目标入组 100 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
There are differences in the abundance of gut microbiota between RLS and theThere are differences in the abundance of gut microbiota between RLS patients and the healthy controls.

研究概览

简要总结

The goal of this observational study is to collect fecal and serum samples from patients with restless legs syndrome (RLS) and healthy controls for differential microbiota analysis to identify key bacterial species involved in the pathogenesis of RLS. Subsequently, metabolomic analysis will be performed on fecal and serum samples from RLS patients to identify key regulatory molecules in iron metabolism disorder pathways. Finally, correlation analysis will be used to determine which specific bacterial species and metabolites are involved in the pathogenesis of RLS. The main question it aims to answer is: i) Do RLS patients exhibit gut microbiota dysbiosis compared to healthy controls? ii) Which specific bacterial species and metabolites are linked to iron metabolism abnormalities and the pathogenesis of RLS?

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
All
接受健康志愿者

入选标准

  • ≥18 years old;
  • The diagnostic criteria all meet the five diagnostic criteria for restless legs syndrome established by the International Committee for the Study of Restless Legs Syndrome (IRLSSG) (2014 revised version)

排除标准

  • Suffering from serious physical illnesses, such as tumors, cardiovascular diseases, diabetes, stroke, etc.;
  • Drug abuse, alcoholism, acute poisoning;
  • Antibiotic use within the 4 weeks preceding sampling;
  • Arobiotics or prebiotics use within the 4 weeks preceding sampling;
  • Iron supplements use within the 4 weeks preceding sampling.

结局指标

主要结局

There are differences in the abundance of gut microbiota between RLS and theThere are differences in the abundance of gut microbiota between RLS patients and the healthy controls.

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Wenxia Jiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wenxia Jiang

Doctor

Chongqing Traditional Chinese Medicine Hospital

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