Clinical trial NCT01479660: Role of Healthy Bacteria in Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: Probiotics
ulcerative colitis
inflammatory bowel disease
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
Collaborators: name: Ministry of Science and Technology, India
First posted: 2011-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in intestinal permeability
timeFrame: 12 weeks
measure: Reduction in faecal and serum inflammatory markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Bikash Medhi, MD
role: PRINCIPAL_INVESTIGATOR
References: