Role of Healthy Bacteria in Ulcerative Colitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2011 by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Recruiting

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

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, 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 ]

Secondary Outcome Measures:

Reduction in intestinal permeability [ Time Frame: 12 weeks ]
Reduction in faecal and serum inflammatory markers [ Time Frame: 12 weeks ]


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
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (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

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


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 )
Study First Received:	November 22, 2011
Last Updated:	November 23, 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

ClinicalTrials.gov processed this record on July 19, 2017

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