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Role of Healthy Bacteria in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01479660
Recruitment Status : Unknown
Verified November 2011 by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Control Drug: Probiotic Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Other: Control
Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose

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




Primary Outcome Measures :
  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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Reduction in intestinal permeability [ Time Frame: 12 weeks ]
  2. Reduction in faecal and serum inflammatory markers [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Registry Identifier: Clinical Trials Registry- India )
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research:
Probiotics
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases