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.
Phase:
Phase 4
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research