Restless Legs Syndrome (RLS)NCT07307482
Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism
An observational study of Restless Legs Syndrome (RLS), run by Wenxia Jiang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome (RLS)
- What is being tested?
- Not applicable- observational study
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥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)
Who cannot join
- 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.
About this study
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)
- Being tested
- Not applicable- observational study
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs Syndrome (RLS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenxia Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenxia Jiang, Chongqing Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307482
- Sponsor's protocol ID
- 2025-IIT-KS-23
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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., 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism
- ClinicalTrials.gov ID
- NCT07307482
- Acronym / sponsor ID
- 2025-IIT-KS-23
- Conditions
- Restless Legs Syndrome (RLS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenxia JiangUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background1. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome (RLS), run by Wenxia Jiang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.