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

NCT ID: NCT07307482

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Restless Legs Syndrome (RLS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Not applicable- observational study

Not applicable- observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* No clinical manifestations of RLS

Exclusion Criteria

* 1\) Suffering from serious physical illnesses, such as tumors, cardiovascular diseases, diabetes, stroke, etc.; 2) Drug abuse, alcoholism, acute poisoning; 3)Antibiotic use within the 4 weeks preceding sampling; 4) Arobiotics or prebiotics use within the 4 weeks preceding sampling; 5)Iron supplements use within the 4 weeks preceding sampling.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenxia Jiang

OTHER

Sponsor Role lead

Responsible Party

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Wenxia Jiang

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type BACKGROUND

Other Identifiers

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2025-IIT-KS-23

Identifier Type: -

Identifier Source: org_study_id