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

Wenxia Jiang

Status: Not yet enrolling

Conditions: Restless Legs Syndrome (RLS)

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07307482

2025-IIT-KS-23

Details and patient eligibility

About

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?

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.