NCT01479660

Role of Healthy Bacteria in Ulcerative Colitis

Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Control	Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
DRUG	Probiotic	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

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-11-24
• Last updated: 2011-11-24

Locations

1 site across 1 country: India