Gut Microbiota: a Player in Chronic Pain in Patients With Rheumatoid Arthritis?

NCT05822856 | Unknown

• 1 other identifier: RECHMPL22_0385
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Fibromyalgia

Keywords

Rheumatoid Arthritis; intestinal microbiota; Faecalibacterium; pain

Outcome Measures

Primary Outcomes (1)

• Comparison of the frequency of intestinal Faecalibacterium between : - inflammation-free RA with persistent chronic pain patients and - RA remission pain-free patients

  Comparison of the frequency of intestinal Faecalibacterium assessed by 16S RNA sequencing from patient stool samples collected in OMNIGene-Gut collection tubes

  Baseline

Secondary Outcomes (28)

• comparison of the frequency of intestinal Faecalibacterium between : - RA in remission without pain patients and RA without inflammation with persistant chronic pain patients - active RA patients

  Baseline

• comparison of the frequency of intestinal Faecalibacterium between : - RA in remission without pain patients and RA without inflammation with persistant chronic pain patients - healthy subjects

  Baseline

• comparison of the frequency of intestinal Faecalibacterium between : - RA in remission without pain patients and RA without inflammation with persistant chronic pain patients - patients with fibromyalgia

  Baseline

• comparison of the metabolites from the microbiota between : - RA in remission without pain patients and RA without inflammation with persistant chronic pain patients - active RA patients

  Baseline

• comparison of the metabolites from the microbiota between : - RA in remission without pain patients and RA without inflammation with persistant chronic pain patients - healthy subjects

  Baseline

Study Arms (5)

Patients with RA without inflammation with persistent chronic pain

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Other: Blood sampling and others interventions

Patients with an active RA (in inflammatory flare)

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Other: Blood sampling and others interventions

Patients with RA in remission without pain

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Other: Blood sampling and others interventions

fibromyalgia patients

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Other: Blood sampling and others interventions

Control subjects: healthy volunteers

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Other: Blood sampling and others interventions

Interventions

Blood sampling and others interventions OTHER

Blood sampling, faeces collection, questionnaires, tactile sensitivity, sensorial tests

Control subjects: healthy volunteers; Patients with RA in remission without pain; Patients with RA without inflammation with persistent chronic pain; Patients with an active RA (in inflammatory flare); fibromyalgia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population with a painful pathology (RA and fibromyalgia) compared to a non-painful population (RA and healthy subjects)

You may qualify if:

• 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),

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU montpellier - department of rheumatology

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and intestinal microbiota (stool) samples taken in the framework of the research will constitute a serum library and a bank of intestinal microbiota

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fibromyalgia; Pain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Claire I DAIEN, MD-PhD

  Centre Hospitalier Universitaire de Montpellier Montpellier

  STUDY DIRECTOR

Central Study Contacts

Claire I DAIEN, MD-PhD

CONTACT

467338710; c-daien@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 21, 2023
• Study Start: July 6, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

FR (1)