Role of Healthy Bacteria in Ulcerative Colitis

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479660

Contacts
Contact: Bikash Medhi, MD +91-1722755250 drbikashus@yahoo.com
Contact: Rakesh Kochhar, MD, DM +91-1722756608 dr_kochhar@hotmail.com

Locations
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         
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
  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 September 11, 2014