A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- improvement of IBS symptoms and quality of life
研究概览
简要总结
Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular bowel movements and bloating. It may be caused by loe degree inflammation of the intestine. The ingredients of coltect which contains green tea, selenium, and curcumin have been proven very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to see whether the use of Coltect can improve symptoms in IBS patients.
详细描述
The etiology of Irritable bowel syndrome is unknown but some evidence suggests it may be caused by a certain degree of inflammation, another theory is that intestinal flora has an influence on IBS. Coltect combines 3 ingredients: green tea, selenium and curcumin, all of which have been shown to have anti inflammatory and anti oxidant activity. the aim of the study is to investigate if use of coltect can improve symptoms in IBS patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS as defined by the Rome III criteria
- •for those above age 40 a colonoscopy within the last 5 years
- •no new treatment in the last 2 weeks
- •not receiving any antibiotics in the last 2 weeks
排除标准
- •any large abdominal operation (such as colectomy) in the past
- •a known disease of the gastrointestinal tract
- •any significant debilitating disease such as sever heart failure, un controlled diabetes,
研究组 & 干预措施
placebo
patients receiving similar capsules but no active ingredients
干预措施: Placebo (Dietary Supplement)
treatment with study drug
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
干预措施: coltect (Dietary Supplement)
结局指标
主要结局
improvement of IBS symptoms and quality of life
时间窗: 10 weeks
improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
次要结局
- change in bacterial stool flora(10 weeks)
研究者
NAFTALI TIMNA
MD
Meir Medical Center