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Role of Healthy Bacteria in Ulcerative Colitis

This study is currently recruiting participants.
Verified November 2011 by Postgraduate Institute of Medical Education and Research
Sponsor:
Collaborator:
Ministry of Science and Technology, India
Information provided by (Responsible Party):
Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01479660
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes

November 22, 2011
November 23, 2011
March 2011
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01479660 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Role of Healthy Bacteria in Ulcerative Colitis
Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • Other: Control
    Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
    Other Name: Control
  • 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
  • Placebo Comparator: Control
    Intervention: Other: Control
  • Experimental: Probiotic
    Intervention: Drug: Probiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Bikash Medhi, MD +91-1722755250 drbikashus@yahoo.com
Contact: Rakesh Kochhar, MD, DM +91-1722756608 dr_kochhar@hotmail.com
India
 
NCT01479660
11/6095 dated 15/03/2011, CTRI/2011/08/001944
No
Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Ministry of Science and Technology, India
Principal Investigator: Bikash Medhi, MD Post Graduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP