Trial to study the gut microbiome in patients with childhood arthritis and see the effect of probiotics on disease
Phase 4
Completed
- Conditions
- Health Condition 1: null- Enthesitis related arthritis category of Juvenile idiopathic arthritisHealth Condition 2: M08- Juvenile arthritisHealth Condition 3: M084- Pauciarticular juvenile rheumatoidarthritis
- Registration Number
- CTRI/2012/08/002871
- Lead Sponsor
- Department of Biotechnology DBT Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method plamsa Levels of cytokines (TNF-alpha, IL-10, IFN-gamma, IL-12p70, IL-6 and IL-4) <br/ ><br>2. Th17 and TregTimepoint: 0 and 12 weeks