Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- inflammatory parameters
研究概览
简要总结
Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres. Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in the regulation of epithelial cell proliferation and differentiation, immune function and mucosal protection.
Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate, which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate enemas have been proven to be effective in the treatment of active ulcerative colitis.
In the present study, the direct effects of butyrate on inflammation and parameters of colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade inflammation in the large intestine, and can therefore be used as a model to study the mechanistic effects of butyrate. The design used to study the effects of butyrate in both patient groups will be a double blind randomized placebo-controlled parallel design.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of UC or Diarrhea predominant IBS
- •Stable western diet
- •Age between 18 and 65
- •BMI between 18 and 35
- •Written informed consent
排除标准
- •All enemas and suppository during or 2 weeks prior to the study
- •Use of corticosteroids during or 1 month prior to the study
- •Use of antibiotics during or 3 months prior to the study
- •Budesonide during or 2 weeks prior to the study
- •Changes in medication during or 1 month prior to the study
- •Lactation, pregnancy and planning of pregnancy
- •Previous intestinal surgery
- •Clinically significant systemic diseases
- •Excessive drinking (>20 alcoholic consumptions per week)
- •Changes in prebiotic and/or probiotic use during and 2 weeks prior to the study
- •Previous radiotherapy or chemotherapy
结局指标
主要结局
inflammatory parameters
时间窗: okt 2008
次要结局
- oxidative stress parameters(okt 2008)