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NCT05985421: RLS-BIOT
Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome
trial testing Fecal collection in Restless Legs Syndrome in 120 participants. Status unknown.
29 March 2025
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 9 January 2024 |
| Primary completion | 29 March 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Fecal collection
- Blood sampling — full drug profile →
- Polysomnography
- Auto questionnaires
Conditions studied
- Restless Legs Syndrome — all drugs for Restless Legs Syndrome →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05985421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Restless Legs Syndrome
Currently open trials in the same condition.
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- NCT06570941 — Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome · Phase 1, PHASE2 · active not recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05985421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 20 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05985421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing