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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Control; Drug: Probiotic

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Post Graduate Institute of Medical education and Research
    • Contact: Bikash Medhi, MD; Phone Number: +91-1722755250; Email: drbikashus@yahoo.com
    • Contact: Rakesh Kochhar, MD, DM; Phone Number: +91-1722756608; Email: dr_kochhar@hotmail.com
    • Principal Investigator: Bikash Medhi, MD
    • Sub-Investigator: Rakesh Kochhar, MD,DM
    • Sub-Investigator: Usha Dutta, MD, DM
    • Sub-Investigator: Pallab Ray, MD
    • Sub-Investigator: Kaushal K Prasad, MD
    • Sub-Investigator: Chetana Vaishnavi, Ph.D
    • Sub-Investigator: Kartar Singh, MD, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Control; Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
Experimental: Probiotic	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Reduction in intestinal permeability	12 weeks
Reduction in faecal and serum inflammatory markers	12 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborators: Ministry of Science and Technology, India
• Investigators: Principal Investigator: Bikash Medhi, MD, Post Graduate Institute of Medical education and Research

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2011
• Last Update Submitted That Met QC Criteria: November 23, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Probiotics; ulcerative colitis; inflammatory bowel disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 11/6095 dated 15/03/2011; CTRI/2011/08/001944 (Registry Identifier: Clinical Trials Registry- India)