Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome — RLS-BIOT  

Restless Legs Syndrome Clinical Trial

Official title: Study of Gut Microbiota and Bacterial Translocation in Patients With Restless Legs Syndrome and Controls

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

• NCT number: NCT05985421
• Study type: Observational
• Source: University Hospital, Montpellier
• Contact: CHENINI Sofiene, Dr
• Phone: 0467332237
• Email: s-chenini@chu-montpellier.fr
• Status: Recruiting
• Start date: January 9, 2024
• Completion date: September 30, 2025