Role of Healthy Bacteria in Ulcerative Colitis

NCT01479660 | Unknown Phase 4

• 2 other identifiers: 11/6095 dated 15/03/2011CTRI/2011/08/001944
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Probiotics; ulcerative colitis; inflammatory bowel disease

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (2)

• Reduction in intestinal permeability

  12 weeks

• Reduction in faecal and serum inflammatory markers

  12 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Other: Control

Probiotic

EXPERIMENTAL

Drug: Probiotic

Interventions

Control OTHER

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

Control

Probiotic DRUG

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

Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Active disease at presentation

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bikash Medhi, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bikash Medhi, MD

CONTACT

+91-1722755250; drbikashus@yahoo.com

Rakesh Kochhar, MD, DM

CONTACT

+91-1722756608; dr_kochhar@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor, Department of Pharmacology

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

IN (1)