Probiotics and Sulphasalazine in the treatment of Rheumatoid Arthritis
Phase 2
- Conditions
- Rheumatoid ArthritisRheumatoid arthritisInflammatory and Immune System - Rheumatoid arthritisMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12608000266369
- Lead Sponsor
- Dr. Simon Stebbings, Dunedin School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Fulfillment of ACR (American College of Rheumatology) criteria of Rheumatoid Arthritis
Taking Sulphasalazine for at least 3 months
If female of reproductive age must be on effective contraception
Exclusion Criteria
Psychiatric illness - major depression, psychosis or dementia
Pregnancy or lactation
Malignancy
Current acute infection - especially Gastro-Intestinal infection
Current treatment with antibiotics
Chronic infection - HIV, hepatitis B + C, EBV, TB
Known allergy to probiotics
Sulphasalazine dose greater than 1g twice daily or 40mg/kg
Symptoms attributable to side effects of sulphasalazine
Significant renal impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in levels of sulphasalazine metabolites (sulphapyridine, 5 aminosalicylic acid and sulphasalazine levels in blood and urine)[At baseline, one week (at completion of course of probiotics) and four weeks.]
- Secondary Outcome Measures
Name Time Method Disease activity of Rheumatoid Arthritis assessed by Disease Activity Score (DAS), which is a count of swollen and/or tender joints combined with the C-reactive protein (CRP) in mg/l- level and patient global assessment score.[At baseline, one week and four weeks.];Side effects of Sulphasalazine as measured by blood full blood count, liver function tests and creatinine.[At baseline, one week and four weeks.]