Role of Healthy Bacteria in Ulcerative Colitis

Phase 4

• Conditions: Ulcerative Colitis
• Interventions: Other: Control; Drug: Probiotic

• Registration Number: NCT01479660
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Study First Posted: 2011-11-24
• Last Update Posted: 2011-11-24
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Probiotic	Probiotic	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reduction in faecal and serum inflammatory markers	12 weeks
Reduction in intestinal permeability	12 weeks

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India