Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the role of gut bacteria in patients with Restless Legs Syndrome (RLS), a condition that causes an irresistible urge to move the legs, especially when resting. Researchers believe that an imbalance in gut bacteria might affect how the body absorbs iron, which is important since many people with RLS have low iron levels. By studying the gut microbiota, they hope to learn more about the relationship between gut health and RLS symptoms.

To participate in this trial, potential candidates must be adults aged 65 to 74 who have been diagnosed with moderate to severe RLS and experience periodic leg movements during sleep. Participants will be asked not to have used certain medications for at least 15 days prior to the study. Those who do not have RLS but have similar characteristics in terms of age and gender may also be eligible as a control group. Participants can expect to provide information about their health and undergo assessments related to their condition. It's important to note that individuals with certain health issues, such as severe sleep apnea or inflammatory diseases, will not be eligible for the study.

Gender

ALL

Eligibility 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.