Role of Healthy Bacteria in Ulcerative Colitis

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase

Unknown

Phase 4

Conditions

Ulcerative Colitis

Treatments

Other: Control

Drug: Probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT01479660

CTRI/2011/08/001944 (Registry Identifier)

11/6095 dated 15/03/2011

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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