Ulcerative Colitis
Conditions
Keywords
Probiotics, ulcerative colitis, inflammatory bowel disease
Brief summary
Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered mucosal immune response to luminal bacterial antigens. Current research suggests that an inappropriate and persistent immune response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has been also proposed that the signs and symptoms of IBD may be mediated by the increased intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased intestinal permeability results in further exposure of underlying intestinal mucosa to luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring intestinal permeability rather than only reduction of mucosal inflammation would thus be a desirable endpoint in the restoration of mucosal integrity and would be the harbinger of better long term outcome. Many clinical trials have shown that probiotics may have beneficial effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they are not clearly established. The role of probiotics in improving intestinal permeability has not been evaluated. The probiotic VSL #3 is easily available, cheap, effective and safe alternative or substitute for the existing therapeutic agents will be evaluated in this study for their efficacy, tolerability, compliance in inducing clinical response in patients with Ulcerative colitis. This will be a double blind randomized placebo controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with inflammatory bowel disease. The objectives of this study are to determine the efficacy of probiotics on clinical endoscopic and histological improvement, to find the improvement in faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal permeability, improvement in Quality of life parameters.
Interventions
OTHERControl
Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
DRUGProbiotic
Probiotic Capsules (450 billion CFU) will be orally administered daily for a period of 12 weeks and Probiotic in higher dose of (3600 billion CFU) will be administered daily for a period of 12 weeks
Sponsors
Ministry of Science and Technology, India
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years * Active disease at presentation
Exclusion criteria
* Pregnant or lactating women * Any patient who has received probiotic in the preceding 4 weeks * Patient with life threatening cardiac, renal, pulmonary or cardiovascular disease * Inability to obtain the informed consent * Severe disease requiring hospitalization / steroids/ anti-cytokine therapy * Patient taking aspirin and other antiplatelet drugs * Patient with uncontrolled diabetes * Patient with Gall stone disease * Patient currently on antibiotic,NSAIDs or indigenous medicine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of at least 3 points in the D.A.I i.e. Reduction in the activity score of inflammation from the baseline value at 12 weeks. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in intestinal permeability | 12 weeks |
| Reduction in faecal and serum inflammatory markers | 12 weeks |
Countries
India
Contacts
Primary ContactBikash Medhi, MD
Backup ContactRakesh Kochhar, MD, DM
Outcome results
None listed