Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable- observational study.
- Who it may be relevant to
- Registry conditions: Restless Legs Syndrome (RLS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Not applicable- observational study
Not applicable- observational study
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 1. Yan, F., Y. Cheng, and S. Feng, Association between serum GFAP, BDNF and NfL levels and clinical symptoms in restless legs syndrome: a case-control study. Sleep Med, 2025. 134: p. 106694. 2. Holland, M.T., et al., Adaptive spinal cord stimulation improves restless legs syndrome: Case report, literature review, and mechanistic hypothesis. Sleep Med, 2025. 134: p. 106664. 3. Takahara, I., et al.,
Identifiers
NCT: NCT07307482 · 2025-IIT-KS-23