Role of Healthy Bacteria in Ulcerative Colitis

Sponsor

Postgraduate Institute of Medical Education and Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT01479660

Collaborator

Ministry of Science and Technology, India (Other)

100

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

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

Primary Outcome Measures

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

Reduction in intestinal permeability [12 weeks]
Reduction in faecal and serum inflammatory markers [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Post Graduate Institute of Medical Education and Research	Chandigarh		India	160012

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

11/6095 dated 15/03/2011
CTRI/2011/08/001944

First Posted:

Nov 24, 2011

Last Update Posted:

Nov 24, 2011

Last Verified:

Nov 1, 2011

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

Probiotics

ulcerative colitis

inflammatory bowel disease

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Nov 24, 2011