Gut Microbiota: a Player in Chronic Pain in Patients With Rheumatoid Arthritis?
Unknown statusNCT05822856
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Although rheumatoid arthritis (RA) treatments are very effective in reducing inflammation, chronic pain persists in 20 to 30% of patients. The intestinal microbiota can participate on the pain pathways and a decrease in Faecalibacterium has been associated with chronic pain and chronic fatigue. RA patients have an altered gut microbiota or dysbiosis. Among the bacteria that are most often differentially represented between RA and control, Faecalibacterium, was also found less abundant in RA patients. The composition of the gut microbiota has never been evaluated in relation to the clinical phenotype of RA patients and in particular to the presence of a diffuse pain. In this study, investigators will test whether the gut microbiota of RA patients, and in particular the decrease of Faecalibacterium, would promote pain sensitization phenomena, and thus, chronic pain despite the control of joint inflammation.
Study details
- Official title
- Gut Microbiota: a Player in the Patients Pain's Sensitization With Rheumatoid Arthritis?
- Conditions
- Interventions
- Other: Blood sampling and others interventions
- Sponsor
- University Hospital, Montpellier
- Start date
- 2023-07-06
- Primary completion
- 2024-11
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: For all : \- Age ≥ 18 years old For A1 Group (3 groups of RA patients of 25 patients each): \- Subject with Rheumatoid Arthritis (RA) meeting the American College of Rheumatology / European League Against Rheumatism ACR/EULAR 2010 criteria, without disease-modifying treatment or with conventional treatment initiated for at least 3 months (at stable dosage for more than 6 weeks) For A1-1 group : active RA * DAS28\>3.2 with increased CRP (\> laboratory standard), * VAS (Visual Analogic Scale)\>5/10 with no other explanation than inflammatory rheumatism For A1-2 group : RA without inflammation with persistent chronic pain (\>3 months) despite control of inflammation and no other identified cause: * no swollen joint, * CRP normal (\< laboratory standard), * VAS\>5/10 For A1-3 groupe : RA in remission without pain: * DAS28 ≤2.6, * no swollen joint, * CRP normal (\< laboratory standard), * VAS≤2/10 For A2 Group (1 group of 25 Fibromyalgia patients): * Subjects with Fibromyalgia meeting 2016 diagnostic criteria * VAS\>5/10 * FIRST (FIbromyalgia Rapid Screening Tool) ≥5 For A3 Group (1 group of 25 healthy subjects ): * healthy and pain-free controls subjects with no progressive disease, * VAS≤2/10, * FIRST =0 Exclusion Criteria: * biological therapy for RA: within the previous year for rituximab, within \< 4 intervals between anti-TNF, anti-IL6R, or CTLA4-Ig injections and within the previous 15 days for JAKi (JAK inhibitor) * Corticosteroids \> 10 mg/d per os at inclusion * Corticosteroids \> 20 mg/d per os or bolus within 15 days prior to inclusion * Non-steroidal anti-inflammatory drugs (NSAIDs) and pain medication in the previous week * Current oral anti-diabetic or proton pump inhibitor (PPI) therapy * Antibiotic therapy in the previous 3 months * Infection, cancer in the last 5 years prior to inclusion * History of other systemic inflammatory/autoimmune diseases * Not affiliated to a social security * Patient unwilling or unable to give consent: patient under guardianship or conservatorship, * Mentally impaired, dementia, language barrier * Patient under court protection * Pregnant or breastfeeding woman * Refusal of written consent
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05822856