Rheumatoid arthritis
Conditions
Interventions
Sponsors
The Second People's Hospital of Jingdezhen
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who fulfill the American College of Rheumatology (ACR) classification criteria for rheumatoid arthritis (RA) and have received a confirmed diagnosis of RA. 2. Aged 18–75 years; both sexes are eligible. 3. Disease activity: Disease Activity Score-28 (DAS28) >= 2.6, indicating active disease with sufficient inflammatory activity to allow observation of therapeutic improvement. 4. Treatment stability: dosage and type of conventional synthetic DMARDs or biologics have remained unchanged for the 3 months before enrolment, so that medication shifts do not confound the results. 5. Willing and able to cooperate fully with the clinical protocol for the entire treatment period. 6. In good mental health with normal cognition; patient (and family when required) has given written informed consent.
Exclusion criteria
Exclusion criteria: 1. Co-existing autoimmune diseases: systemic lupus erythematosus, scleroderma, Sjögren’s syndrome, polymyositis/dermatomyositis, systemic vasculitis, etc.; their pathophysiology may overlap with RA and confound assessment of RA activity or the effect of Lactiplantibacillus plantarum. 2. Severe infectious diseases: active hepatitis, tuberculosis or other chronic infections, or any acute infection within 1 month before enrolment; infections can trigger/exacerbate RA and alter gut microbiota, complicating interpretation. 3. Gastro-intestinal disorders: severe malabsorption, inflammatory bowel disease (Crohn’s disease, ulcerative colitis), intestinal obstruction, GI malignancies—conditions that per se disturb microbial structure and probiotic efficacy. 4. Pregnancy or lactation: hormonal and immunological changes may influence both RA activity and microbiota; safety of probiotics in this group is unclear; therefore excluded. 5. Known hypersensitivity to probiotics or dairy products: to prevent allergic reactions to L. plantarum and ensure patient safety. 6. Major cardio-cerebrovascular disease: unstable angina, recent myocardial infarction, heart failure (NYHA III–IV), severe arrhythmia, acute cerebral infarction, etc.; these conditions may interfere with RA outcome measures and compromise trial continuity. 7. Severe psychiatric or neurological disorders: schizophrenia, major depression, Alzheimer’s disease, etc., that impair comprehension or compliance with study procedures. 8. Laboratory abnormalities: WBC 12.0 × 10?/L, platelets 400 × 10?/L, suggesting occult infection, hematologic disease or systemic illness that could bias results or increase risk. 9. Patients who refuse study procedures or are judged by the investigator to have poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut microbiota;Disease Activity Score (DAS28);Number of joint tenderness and joint swelling;erythrocyte sedimentation rate;C-reactive protein (CRP);Rheumatoid factor (RF);anti-cyclic peptide containing citrulline, anti-CCP;visual analogue pain scale;quality of life; | — |
Countries
China
Contacts
Public ContactHongying Yu
The Second People's Hospital of Jingdezhen
Outcome results
None listed