Role of Healthy Bacteria in Ulcerative Colitis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Other: Control; Drug: Probiotic	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial
Study Start Date :	March 2011
Estimated Primary Completion Date :	October 2014
Estimated Study Completion Date :	October 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Reduction in intestinal permeability [ Time Frame: 12 weeks ]
2. Reduction in faecal and serum inflammatory markers [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Bikash Medhi, MD	+91-1722755250	drbikashus@yahoo.com
Contact: Rakesh Kochhar, MD, DM	+91-1722756608	dr_kochhar@hotmail.com

Locations

India
Post Graduate Institute of Medical Education and Research	Recruiting
Chandigarh, India, 160012
Contact: Bikash Medhi, MD +91-1722755250 drbikashus@yahoo.com
Contact: Rakesh Kochhar, MD, DM +91-1722756608 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

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Ministry of Science and Technology, India

Investigators

Principal Investigator:	Bikash Medhi, MD	Post Graduate Institute of Medical Education and Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Additional Professor, Department of Pharmacology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:	NCT01479660 History of Changes
Other Study ID Numbers:	11/6095 dated 15/03/2011; CTRI/2011/08/001944 ( Registry Identifier: Clinical Trials Registry- India )
First Posted:	November 24, 2011
Last Update Posted:	November 24, 2011
Last Verified:	November 2011

Keywords provided by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research:

Probiotics; ulcerative colitis; inflammatory bowel disease

Additional relevant MeSH terms:

Colitis; Ulcer; Colitis, Ulcerative; Gastroenteritis; Gastrointestinal Diseases	Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases