"A Randomized control trial to study the effect of oral probiotic versus placebo in patients with ulcerative colitis on clinical/endoscopic response intestinal permeability and fecal and serum markers of mucosal inflammation in addition to standard therapy"
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Response will be defined as reduction of atleast 3 points in the UCDAI from the baseline value at 12 weeks; reduction in the activity score of inflammation
研究概览
简要总结
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 immuno response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory bowel disease . It also has been 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 and 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 objective 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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Active disease at presentation.
排除标准
- •Patient should not be on antibiotic, NSAIDs or indigenous medicine Pregnant or lactating mother Any patient who received probiotic in the preceding 4 weeks Patient with life threatning cardiac, renal, pulmonary or cardiovascular disease Inability to obtain informed consent Severe disease requiring hospitalization /steroids /anti-cytokine therapy Patient taking antiplatelet drugs Patient with uncontrolled diabetes patient with gall stone disease.
结局指标
主要结局
Response will be defined as reduction of atleast 3 points in the UCDAI from the baseline value at 12 weeks; reduction in the activity score of inflammation
时间窗: 12 weeks
次要结局
- Reduction in intestinal permeability(Reduction in faecal and serum inflammatory markers)