Health Condition 1: null- Enthesitis related arthritis category of Juvenile idiopathic arthritis Health Condition 2: M08- Juvenile arthritis Health Condition 3: M084- Pauciarticular juvenile rheumatoidarthritis
Conditions
Interventions
Intervention1: VSL3 capsules containing 112.5 billion cells: VSL3 capsule containing 112.5 billion cells twice daily orally for 12 weeks
Control Intervention1: placebo: will be comparable to the activ
Sponsors
Department of Biotechnology DBT Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of JIA-ERA as per ILAR criteria 2. Active disease as defined by presence of active arthritis (swollen joints)/enthesitis with elevated erythrocyte sedimentation rate ( >30 mm in first hour). 3. Consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics in the previous 6 weeks 2. History of diarrhea in the previous 6 weeks 3. Use of drugs that alter gut motility in the previous 6 weeks 4. Use of corticosteroids or disease-modifying anti-rheumatic drugs (DMARDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disease activity as measured by like number of swollen joints, number of tender joints, enthesitis index, BATH disease activity index, ESR and CRP. In addition requirement of NSAIDs used will also be monitored to see if that reduces with use of probioticsTimepoint: 0,6,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| plamsa Levels of cytokines (TNF-alpha, IL-10, IFN-gamma, IL-12p70, IL-6 and IL-4) 2. Th17 and TregTimepoint: 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactAmita Aggarwal
SGPGI, Lucknow
Outcome results
None listed