The Effect of Beta-glucan on Faecal Microflora in Polypectomized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH).
研究概览
简要总结
The aim of this study is to determine the effect of the potential prebiotic beta-glucan on the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and beta-glucosidase) in the feces, the fecal pH and the concentration of fecal short-chain fatty acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal water will be examined on human cell culture (HT29). During the trial, patient's clinical symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.
详细描述
Prebiotics, such as short- and long-chain fructo-oligosaccharides are fermented by the microflora colonizing the gastrointestinal tract, and they selectively stimulate the growth or the activity of one or limited number of bacteria within the intestine. Beta-glucans are polysaccharides occurring in the bran of cereal grains, the cell wall of Saccharomyces cerevisiae and bacteria, certain types of fungi, seaweed and many kinds of mushrooms. The aim of this study is to determine the effect of the potential prebiotic beta-glucan on the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and beta-glucosidase) in the faeces, the faecal pH, and the concentration of faecal short-chain fatty acid in polypectomized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects must have biopsy and histologically confirmed adenomatous polyps ≥ 1cm in size or ≥ 3 in number with moderate or severe dysplasia
排除标准
- •Subjects ≥ 75 years of age
- •Subjects who are pregnant or desire to become pregnant during the study period
- •Subjects who are considered to be poor clinic attendees
- •Subjects who have been on antibiotics within the previous month or are likely to require antibiotics during the trial
- •Subjects who consume prebiotics or probiotics within the previous month or are likely to require antibiotics during the trial
- •Subjects with colon cancer
- •Subjects with additional gastrointestinal disorders (e.g., Crohn's disease or ulcerative colitis)
- •Subjects with malignancy or any end-stage organ disease
研究组 & 干预措施
wheat bread with beta-glucan supplementation
干预措施: wheat bread with beta-glucan (Dietary Supplement)
wheat bread without beta-glucan
干预措施: wheat bread without beta-glucan (Dietary Supplement)
结局指标
主要结局
To measure the effect of beta-glucan on fecal microflora (number of bacteria, bacterial enzyme activity, SCFA, pH).
时间窗: four months
To observe the effect of beta-glucan on intestinal symptoms and well-being.
时间窗: four months
次要结局
- To study the fecal water cyto- and/or genotoxicity on HT-29 cell line.(one year)
研究者
Kyriacou Adamantini
Assistant Professor
Harokopio University