Clinical trial of Biotherapi®, a probiotic supplement, as an additional therapy in the treatment of rheumatoid arthritis

INTERVENTION: Patients with rheumatoid arthritis were randomized 1:1 into two groups. Patients in the intervention group received adjunctive probiotic supplement (capsules) for rheumatoid arthritis, and patients in the nonintervention group (n=125) received only the standard of care treatment. Every alternate patient received adjunctive probiotic as per protocol. Each probiotic capsule contained not less than (NLT) 5 billion colony‐forming units (CFUs) of B. subtilis (SNZ 1972) and B. coagulans (SNZ 1969). The standard of care treatment consisted of methotrexate, hydroxychloroquine, sulphasalazine, leflunomide, and methylprednisolone. One capsule of the probiotic supplement was self‐administered twice‐daily for a period of 90 days (3 months). On‐going medication and/or additional therapy such as physiotherapy were allowed. Patients were observed at two follow‐up visits after randomization over the course of 90 days on days 45 and 90. CONDITION: Rheumatoid arthritis ; Musculoskeletal Diseases ; Rheumatoid arthritis PRIMARY OUTCOME: Disease Activity Score‐28‐Erythrocyte Sedimentation rate (DAS‐28‐ESR) measured by blood test at baseline, day 45, and day 90 SECONDARY OUTCOME: ; At baseline, day 45, and day 90:; Symptoms of RA measured using:; 1. Clinical disease activity index (CDAI); 2. Tender joint count (TJC); 3. Swollen joint count (SJC); 4. Patient general assessment score; 5. Physician Global Assessment of Disease Activity Score; 6. General health measured using the Health assessment questionnaire (HAQ) score; INCLUSION CRITERIA: 1. Between the age of 18 to 75 2. Clinically diagnosed with RA (according to ACR 2010 criteria) 3. Active disease defined by DAS28ESR >2.6 4. On RA treatment for at least 3 months and are expected to stay on stable dose throughout the study duration (i.e ongoing medication and/or other therapy such as physiotherapy are permitted, except immunotherapy)