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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07307482
Enrollment
100
Registered
2025-12-29
Start date
2025-12-15
Completion date
2026-12-31
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome (RLS)

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?

Interventions

OTHERNot applicable- observational study

Not applicable- observational study

Sponsors

Wenxia Jiang
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
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.1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026