Stability of the Intestinal Microbiome in Patients Suffering From Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) Under the Influence of an Osmotic Laxans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of the microbiome
研究概览
简要总结
In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.
详细描述
I
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months
- •patients with the indication for colonoscopy
排除标准
- •age under 18
- •pregnancy
- •new therapy planned
- •change of therapy within the last three months
- •acute exacerbation of the inflammatory bowel disease
- •colon pathologies of other origin: colocarcinoma, Illnesses with diarrhea (f.e.microscopic colitis), short bowel syndrome, malabsorption, colectomy
- •intake of antibiotics in the last three months
- •intake of probiotics in the last month
- •intake of antibiotics or probiotics during the study
- •new proton pump inhibitor therapy
- •significant change of nutrition in the last three months
- •holidays outside europe in the last month
- •gastroenteritis in the last three months
- •intake of laxatives
- •nonsteroidal antiinflammatory drugs should be avoided and documented
研究组 & 干预措施
Inflammatory bowel disease
The aim is to recruit 20 persons suffering from Crohn's disease or ulcerative colitis with stable medication and stable control of the disease.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.
干预措施: Macrogol (Drug)
Irritable bowel syndrome
The aim is to recruit 20 persons suffering from irritable bowel syndrome (IBS) fulfilling rome criteria.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.
干预措施: Macrogol (Drug)
Healthy
The aim is to recruit 20 persons without known illnesses with a comparable age to the other two groups.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.
干预措施: Macrogol (Drug)
结局指标
主要结局
Changes of the microbiome
时间窗: 4 months
The investigators aim to asses the changes of the gut microbiome between the three Groups and before and after lavage (Alpha Diversity, Beta Diversity, Group Significance)
次要结局
未报告次要终点