Exploring the role of gut bacteria in chronic pain for rheumatoid arthritis patients
Gut Microbiota: a Player in the Patients Pain's Sensitization With Rheumatoid Arthritis?
This study is trying to see if certain gut bacteria affect chronic pain in people with rheumatoid arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05822856 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiota and chronic pain in patients with rheumatoid arthritis (RA). It focuses on the presence of Faecalibacterium, a type of gut bacteria that has been associated with pain and fatigue. The study will categorize RA patients based on their pain levels and inflammation status, examining how variations in gut microbiota may influence pain sensitization. Blood samples and other interventions will be utilized to gather data on the gut microbiome and its potential impact on pain perception.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with rheumatoid arthritis, particularly those experiencing chronic pain despite controlled inflammation.
Not a fit: Patients with rheumatoid arthritis who do not experience chronic pain or have other underlying causes for their pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into managing chronic pain in rheumatoid arthritis patients by targeting gut microbiota.
How similar studies have performed: While the role of gut microbiota in pain pathways is an emerging field, this specific investigation into its relationship with rheumatoid arthritis and chronic pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- CHU montpellier - department of rheumatology — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Claire I DAIEN, MD-PhD
- Email: c-daien@chu-montpellier.fr
- Phone: 467338710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.