Role of healthy bacteria in ulcerative colitis.
Phase 4
- Conditions
- Health Condition 1: null- Active Ulcerative colitis disease
- Registration Number
- CTRI/2011/08/001944
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
Active disease at presentation
Exclusion Criteria
Patient should not be on antibiotic, NSAIDs or indigenous medicine
Pregnant or lactating mother
Any patient who received probiotic in the preceding 4 weeks
Patient with life threatning cardiac, renal, pulmonary or cardiovascular disease
Inability to obtain informed consent
Severe disease requiring hospitalization /steroids /anti-cytokine therapy
Patient taking antiplatelet drugs
Patient with uncontrolled diabetes
patient with gall stone disease
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response will be defined as reduction of atleast 3 points in the UCDAI from the baseline value at 12 weeks; reduction in the activity score of inflammationTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Reduction in intestinal permeability <br/ ><br> <br/ ><br>Reduction in faecal and serum inflammatory markersTimepoint: 12 weeks