Exploring gut microbiota's role in Restless Legs Syndrome
Study of Gut Microbiota and Bacterial Translocation in Patients With Restless Legs Syndrome and Controls
University Hospital, Montpellier · NCT05985421
This study is trying to see if the balance of bacteria in the gut affects iron levels and symptoms in people with Restless Legs Syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05985421 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiota and bacterial translocation in patients with Restless Legs Syndrome (RLS). It aims to include 60 patients diagnosed with idiopathic RLS and 60 control subjects to analyze factors such as iron metabolism and chronic inflammation. Participants will undergo fecal collection, blood sampling, polysomnography, and complete questionnaires to gather comprehensive data. The study seeks to understand how dysbiosis may affect iron absorption and contribute to RLS symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate to very severe idiopathic Restless Legs Syndrome who have not been treated with certain medications for at least 15 days.
Not a fit: Patients with digestive, inflammatory, psychiatric, or neurological conditions, or those currently using medications that may affect RLS, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the management of Restless Legs Syndrome by addressing gut health and iron metabolism.
How similar studies have performed: While numerous studies have linked RLS with gastrointestinal diseases, this specific investigation into gut microbiota and RLS is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. * 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. Inclusion Criteria: Control * Adults without RLS with demographic characteristics similar to patients in terms of age (+- 5 years) and gender Exclusion Criteria: 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.
Where this trial is running
Montpellier
- 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, France (RECRUITING)
Study contacts
- Principal investigator: DAUVILLIERS Yves, Pr — Head of Sleep/Wake Unit National reference center for orphan diseases Narcolepsy and hypersomnia
- Study coordinator: CHENINI Sofiene, Dr
- Email: s-chenini@chu-montpellier.fr
- Phone: 0467332237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Restless Legs Syndrome, Periodic legs movement, Gut microbiota, Chronic inflammation, Iron metabolism