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Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome

NCT05985421 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

OTHER

Fecal collection

approximate volume of 2 ml

OTHER

Blood sampling

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

OTHER

Polysomnography

Polysomnography

OTHER

Auto questionnaires

International RLS Study Group Severity Scale, Epworth Sleepiness Scale, Insomnia Severity Index, Beck Depression Inventory-II, Autonomic symtoms scale (SCOPA-AUT)

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • DAUVILLIERS Yves, Pr · Head of Sleep/Wake Unit National reference center for orphan diseases Narcolepsy and hypersomnia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2025-03-29
Completion
2025-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985421 on ClinicalTrials.gov