Restless Legs SyndromeRLS-BIOTNCT05985421
Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome
An observational study of Restless Legs Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Restless Legs Syndrome (RLS) is a common neurological sensorimotor disorder defined by an urge to move the legs when at rest that increase in the evening and at night. The pathophysiology of RLS remains poorly understood, but brain iron deficiency plays a major role. 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
- What is being tested?
- Fecal collection, Blood sampling and Polysomnography
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 60 patients with RLS and 60 controls meeting all criteria, with the aim of having 50 analyzable subjects per group (i.e. with available stool samples).
Who may be able to join
- Patient
- Idiopathic RLS diagnosed according to the 5 clinical criteria established by the IRLSSG (International Restless Legs Syndrome Study Group).
- Moderate to very severe RLS, IRLSSG questionnaire ≥ 15.
- Presence of periodic leg movements (PLM) during sleep (PLM index > 15/hour of sleep).
- Patient never treated or weaned at least 15 days prior to evaluation with dopaminergic agonists, alpha-2delta ligands, opioids or other psychotropic drugs.
- Control
- Adults without RLS with demographic characteristics similar to patients in terms of age (+- 5 years) and gender
Who cannot join
- Patient
- Presence of digestive, inflammatory, psychiatric or neurological pathologies.
- C-reactive protein > 10mg/l (marker of acute inflammation)
- Presence of moderate-to-severe sleep apnea syndrome (apnea-hypopnea index >15/h).
- History of iron supplementation within 6 months.
- Use of treatments known to aggravate or cause RLS, such as antidepressants, neuroleptics, antihistamines or lithium.
Show all 20Show fewer
- Refusal of consent after information
- legally protected adult (guardianship, curatorship)
- Pregnant or breast-feeding women
- Patient not affiliated to or not benefiting from a social security system.
- Control
- Presence of gastrointestinal, inflammatory, psychiatric or neurological diseases.
- C-reactive protein > 10mg/l (marker of acute inflammation).
- Presence of PLM in sleep (threshold >15 per hour of sleep).
- Treatment with antidepressants, neuroleptics, antihistamines, lithium, antiepileptics, benzodiazepines, hypnotics, opiates, dopaminergic agonists, levodopa, alpha-2delta ligands.
- Presence of moderate to severe sleep apnea syndrome (apnea-hypopnea index >15/h)
- Refusal of consent after information
- legally protected adult (guardianship, curatorship)
- Pregnant or breast-feeding woman
- Participant not affiliated to a social security scheme or not benefiting from such a system.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité des troubles du sommeil et de l'éveil-Centre de référence narcolepsie-Hypersomnie/Département de Neurologie/ Pole neurosciences tête et cou Hôpital Gui De Chauliac
Montpellier, 34295
About this study
Official title: Study of Gut Microbiota and Bacterial Translocation in Patients With Restless Legs Syndrome and Controls
Restless Legs Syndrome (RLS) is a common neurological sensorimotor disorder defined by an urge to move the legs when at rest that increase in the evening and at night. The pathophysiology of RLS remains poorly understood, but brain iron deficiency plays a major role. Iron absorption is an active process located in enterocytes of the proximal bowel, and is inhibited by hepcidin. The gut microbiota plays a central role in intestinal absorption, and in the maturation of the immune system. An imbalance in the microbiota, known as dysbiosis, could lead to a decrease in iron absorption, inflammation of the intestinal epithelium, and an increase in its permeability, thus favoring bacterial translocation and chronic systemic inflammation. Numerous studies showed an association between RLS and gastrointestinal diseases: Irritable bowel syndrome, Crohn's disease, ulcerative colitis, small intestinal bacterial overgrowth. However, no study has examined the gut microbiota in RLS.
The investigators hypothesize that there is an imbalance of gut microbiota in patients with RLS, favoring an increased intestinal permeability and bacterial translocation, leading to chronic inflammation and reduced iron bioavailability.
Read the detailed description
Sixty patients with RLS will be included and 60 controls. The patients will be recruited from the active file of the sleep and wake disorders unit.
The control subjects will be recruited from :
- Patients hospitalized for suspected sleep disorders with normal PSG.
- The healthy controls of the RLS cognition protocol, ongoing in the department (ID-RCB: 2012-A00581-42, NCT01823354).
The patients will be informed of the study during a medical consultation. The consent of subjects participating in the study will be obtained during the pre-inclusion visit (D-1). The referring physician of the patients with RLS will propose them to participate in the study. After being duly informed of the nature, significance, implications of the study and appropriately documented by one of the investigators, and after sufficient time for reflection, free, informed and written consent will be obtained from all patients.
The control subjects will receive information about the study when they are admitted to hospital for polysomnographic recording, they will sign their consent for. A clinical examination will also be carried out.
- Conditions
- Restless Legs Syndrome
- Being tested
- Fecal collection, Blood sampling, Polysomnography, Auto questionnaires
- Keywords
- Periodic legs movement, Gut microbiota, Chronic inflammation, Iron metabolism
- 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.
Fecal collectionOther
approximate volume of 2 ml
Blood samplingOther
1 EDTA tube (7 ml) to test for chronic low-grade inflammation + 1 EDTA tube (7 ml) to test for intestinal inflammation, digestive permeability and microbial translocation
PolysomnographyOther
Polysomnography
Auto questionnairesOther
International RLS Study Group Severity Scale, Epworth Sleepiness Scale, Insomnia Severity Index, Beck Depression Inventory-II, Autonomic symtoms scale (SCOPA-AUT)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Fecal collection; Other: Blood sampling; Other: Polysomnography; Other: Auto questionnaires | |
| Control | Not described Receives: Other: Fecal collection; Other: Blood sampling; Other: Polysomnography; Other: Auto questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taxonomic composition of gut microbiota
Diversity (alpha and beta), abundance, nature and relative quantification of bacterial genera and bacterial taxonomic units (OTUs) present in stool samples identified by metagenomics.
Measured: 24 months
Secondary outcomes (1)
Ratio between Firmicutes and Bacteroidetes (majority phyla)
Richness, diversity and importance of minority phyla in stools, distribution and importance of bacterial genera in patients and controls. The study of the intestinal microbiota will consist of a metabarcoding approach to the V3-V4 regions of the 16S rRNA.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start9 Jan 2024
- Primary completion29 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAUVILLIERS Yves, Pr, Principal investigator, Head of Sleep/Wake Unit National reference center for orphan diseases Narcolepsy and hypersomnia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985421
- Sponsor's protocol ID
- RECHMPL23_0083
- Acronym
- RLS-BIOT
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gut Microbiota and Bacterial Translocation in Patients With Restless Legs Syndrome and Controls
- ClinicalTrials.gov ID
- NCT05985421
- Acronym / sponsor ID
- RLS-BIOT / RECHMPL23_0083
- Conditions
- Restless Legs Syndrome
- Keywords
- Periodic legs movement, Gut microbiota, Chronic inflammation, Iron metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 29 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Restless Legs Syndrome (RLS) is a common neurological sensorimotor disorder defined by an urge to move the legs when at rest that increase in the evening and at night. The pathophysiology of RLS remains poorly understood, but brain iron deficiency plays a major role. Iron absorption is an active process located in enterocytes of the proximal bowel, and is inhibited by hepcidin. The gut microbiota plays a central role in intestinal absorption, and in the maturation of the immune system. An imbalance in the microbiota, known as dysbiosis, could lead to a decrease in iron absorption, inflammation of the intestinal epithelium, and an increase in its permeability, thus favoring bacterial translocation and chronic systemic inflammation. Numerous studies showed an association between RLS and gastrointestinal diseases: Irritable bowel syndrome, Crohn's disease, ulcerative colitis, small intestinal bacterial overgrowth. However, no study has examined the gut microbiota in RLS.
The investigators hypothesize that there is an imbalance of gut microbiota in patients with RLS, favoring an increased intestinal permeability and bacterial translocation, leading to chronic inflammation and reduced iron bioavailability.
Detailed description
Sixty patients with RLS will be included and 60 controls. The patients will be recruited from the active file of the sleep and wake disorders unit.
The control subjects will be recruited from :
- Patients hospitalized for suspected sleep disorders with normal PSG.
- The healthy controls of the RLS cognition protocol, ongoing in the department (ID-RCB: 2012-A00581-42, NCT01823354).
The patients will be informed of the study during a medical consultation. The consent of subjects participating in the study will be obtained during the pre-inclusion visit (D-1). The referring physician of the patients with RLS will propose them to participate in the study. After being duly informed of the nature, significance, implications of the study and appropriately documented by one of the investigators, and after sufficient time for reflection, free, informed and written consent will be obtained from all patients.
The control subjects will receive information about the study when they are admitted to hospital for polysomnographic recording, they will sign their consent for. A clinical examination will also be carried out.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Fecal collection, Other: Blood sampling, Other: Polysomnography, Other: Auto questionnaires |
| Control | – | Other: Fecal collection, Other: Blood sampling, Other: Polysomnography, Other: Auto questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with RLS and 60 controls meeting all criteria, with the aim of having 50 analyzable subjects per group (i.e. with available stool samples).
Key inclusion criteria (7 listed)
- Patient
- Idiopathic RLS diagnosed according to the 5 clinical criteria established by the IRLSSG (International Restless Legs Syndrome Study Group).
- Moderate to very severe RLS, IRLSSG questionnaire ≥ 15.
- Presence of periodic leg movements (PLM) during sleep (PLM index > 15/hour of sleep).
- Patient never treated or weaned at least 15 days prior to evaluation with dopaminergic agonists, alpha-2delta ligands, opioids or other psychotropic drugs.
Key exclusion criteria (20 listed)
- Patient
- Presence of digestive, inflammatory, psychiatric or neurological pathologies.
- C-reactive protein > 10mg/l (marker of acute inflammation)
- Presence of moderate-to-severe sleep apnea syndrome (apnea-hypopnea index >15/h).
- History of iron supplementation within 6 months.
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 |
|---|---|---|
| Fecal collectionapproximate volume of 2 ml | Other | Control, Patients |
| Blood sampling1 EDTA tube (7 ml) to test for chronic low-grade inflammation + 1 EDTA tube (7 ml) to test for intestinal inflammation, digestive permeability and microbial translocation | Other | Control, Patients |
| PolysomnographyPolysomnography | Other | Control, Patients |
| Auto questionnairesInternational RLS Study Group Severity Scale, Epworth Sleepiness Scale, Insomnia Severity Index, Beck Depression Inventory-II, Autonomic symtoms scale (SCOPA-AUT) | Other | Control, Patients |
Primary outcome
Taxonomic composition of gut microbiota
Time frame: 24 months
Diversity (alpha and beta), abundance, nature and relative quantification of bacterial genera and bacterial taxonomic units (OTUs) present in stool samples identified by metagenomics.
1 secondary outcome
Ratio between Firmicutes and Bacteroidetes (majority phyla)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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. This study is not recruiting at the moment.
DAUVILLIERS Yves, Pr principal investigator
Head of Sleep/Wake Unit National reference center for orphan diseases Narcolepsy and hypersomnia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHENINI Sofiene, Dr (0467332237 ext. 33, s-chenini@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taxonomic composition of gut microbiota (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2024.