Role of Healthy Bacteria in Ulcerative Colitis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Other: Control Drug: Probiotic |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Reduction in intestinal permeability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Reduction in faecal and serum inflammatory markers [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Control |
Other: Control
Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
Other Name: Control
|
| 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
Other Name: Probiotic
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Bikash Medhi, MD | +91-1722755250 | drbikashus@yahoo.com |
| Contact: Rakesh Kochhar, MD, DM | +91-1722756608 | dr_kochhar@hotmail.com |
| 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 | |
| Principal Investigator: | Bikash Medhi, MD | Post Graduate Institute of Medical Education and Research |
More Information
No publications 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 History of Changes |
| Other Study ID Numbers: | 11/6095 dated 15/03/2011, CTRI/2011/08/001944 |
| Study First Received: | November 22, 2011 |
| Last Updated: | November 23, 2011 |
| Health Authority: | India: Central Drugs Standard Control Organization |
Keywords provided by Postgraduate Institute of Medical Education and Research:
|
Probiotics ulcerative colitis inflammatory bowel disease |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013