Role of Healthy Bacteria in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01479660
• Other study ID #: 11/6095 dated 15/03/2011
• Secondary ID: CTRI/2011/08/001
• Status: Recruiting
• Phase: Phase 4
• First received: November 22, 2011
• Last updated: November 23, 2011
• Start date: March 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2011
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Bikash Medhi, MD
• Phone: +91-1722755250
• Email: drbikashus[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Control
Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose

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

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Ministry of Science and Technology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Reduction in intestinal permeability		12 weeks	Yes
Secondary	Reduction in faecal and serum inflammatory markers		12 weeks	Yes