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Clinical Trials/NCT07307482
NCT07307482
Not yet recruiting
Not Applicable

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

Wenxia Jiang0 sites100 target enrollmentStarted: December 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Wenxia Jiang
Enrollment
100
Primary Endpoint
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.

Overview

Brief Summary

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?

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • ≥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)

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Wenxia Jiang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Wenxia Jiang

Doctor

Chongqing Traditional Chinese Medicine Hospital

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