Role of healthy bacteria in ulcerative colitis.

Not Applicable

Recruiting

Conditions: Active Ulcerative colitis disease

Registration Number: CTRI/2011/08/001944

Lead Sponsor: Department of Biotechnology

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 immuno response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory bowel disease . It also has been 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 and 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 objective 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

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 inflammation	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in intestinal permeability	Reduction in faecal and serum inflammatory markers

Trial Locations

Locations (1): Department of Gastroenterology
🇮🇳
Chandigarh, CHANDIGARH, India
Department of Gastroenterology
🇮🇳Chandigarh, CHANDIGARH, India
Dr Rakesh Kochhar
Principal investigator
dr_kochhar@hotmail.com