The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- endothelial stem cells
研究概览
简要总结
Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.
详细描述
This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids
排除标准
- •pregnant women, under 18 years or over 60 years,
- •patients with known ulcerative colitis,
- •patients with any cancer,
- •patients with heart failure
研究组 & 干预措施
Probiotic
To study the effect of probiotic on the ability to build endothelial progenitor stem cells and to study clinical recovery of patients with Crohn's Disease.
干预措施: Probiotic (Drug)
placebo
This will be the comparison group to the experimantal group that recives Probiotic.
干预措施: Placebo (Drug)
结局指标
主要结局
endothelial stem cells
时间窗: one year
to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group
次要结局
未报告次要终点
研究者
Arnon Blum
Doctor
The Baruch Padeh Medical Center, Poriya