NCT07307482

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Wenxia Jiang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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?

Conditions

• Restless Legs Syndrome (RLS)

Interventions

Type	Name	Description
OTHER	Not applicable- observational study	Not applicable- observational study

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-29
• Last updated: 2026-01-02