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NCT Number: NCT07307482

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

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?

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Key information

Conditions

Restless Legs Syndrome (RLS) Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wenxia Jiang

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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