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

NCT07307482 | Not Yet Recruiting

• 1 other identifier: 2025-IIT-KS-23
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Restless Legs Syndrome (RLS)

Outcome Measures

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.

  1 year

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will recruit 50 patients with restless legs syndrome from among those attending the Sleep Medicine Center of Chongqing Traditional Chinese Medicine Hospital during the period December 2025 to December 2026.

You may qualify if:

• ≥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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenxia Jiang: lead

Related Publications (1)

• 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., Prevalence of Restless Legs Syndrome in Patients with Inflammatory Bowel Disease. Dig Dis Sci, 2017. 62(3): p. 761-767. 4. Loosen, S.H., et al., Association between Inflammatory Bowel Disease and Subsequent Development of Restless Legs Syndrome and Parkinson's Disease: A Retrospective Cohort Study of 35,988 Primary Care Patients in Germany. Life (Basel), 2023. 13(4). 5. Hackethal, S., et al., Restless Legs Syndrome During Pregnancy and Puerperium. Sleep, 2025. 6. Elangovan, P., et al., Prevalence of Restless Leg Syndrome and Its Association With Iron Deficiency in Patients With Chronic Kidney Disease: A Cross-Sectional Observational Study. Cureus, 2025. 17(6): p. e86188. 7. Schormair, B., et al., Genome-wide meta-analyses of restless legs syndrome yield insights into genetic architecture, disease biology and risk prediction. Nat Genet, 2024. 56(6): p. 1090-1099. 8. Manconi, M., et al., Restless legs syndrome. Nat Rev Dis Primers, 2021. 7(1): p. 80. 9. Guo, X., et al., Clinical feature and alpha-synuclein level of restless legs syndrome with leucine-rich repeat kinase 2 encoding gene mutation. Parkinsonism Relat Disord, 2025. 138: p. 107944. 10. Earley, C.J., et al., Altered brain iron homeostasis and dopaminergic function in Restless Legs Syndrome (Willis-Ekbom Disease). Sleep Med, 2014. 15(11): p. 1288-301. 11. Mizuno, S., et al., CSF iron, ferritin and transferrin levels in restless legs syndrome. J Sleep Res, 2005. 14(1): p. 43-7. 12. Ferré, S., et al., New Insights into the Neurobiology of Restless Legs Syndrome. Neuroscientist, 2019. 25(2): p. 113-125.

  BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share