KOLBIBAKT; The Association Between the Microbiological Environment in Colon and Colorectal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,257
- 主要终点
- Bacterial diversity in colorectal disease
研究概览
简要总结
Colorectal illness contributes significantly to the global burden of disease. Cancer, inflammatory bowel disease and diverticulosis result in substantial patients suffering and health care expenditures. The causes of colorectal diseases remain unclear.
New data suggests that intestinal bacteria may play a major role in the causal chain for many diseases, and the research on the microbial environment in the colon in relation to bowel disease is increasingly intense although the possibility for analysis of the composition of bacteria in the gut has so far been limited. However, new analytic methods based on powerful DNA sequencing, opens new opportunities.
In the surgical clinic at Danderyds hospital, Stockholm, 2500 colonoscopies are performed per year. The investigators have created a biobank with mucosal samples from patient's large bowel and will consecutively include all patients scheduled for colonoscopy during one year (N=2500). Biopsies from the colonic mucosa will be analysed in collaboration with the Clinical Genomics, Science for Life laboratory (Karolinska Institutet).
In Phase 1, the association between specific bacteria and colorectal disease will be investigated (hypothesis generating phase). In Phase 2, the investigators aim to identify specific bacterial biomarkers that could be used as screening tools, and lay the ground for future new treatments for colorectal disease.
Early detection and new treatment regimes would result in both significant patient benefits as well as reductions in healthcare costs.
详细描述
Project description Overall hypothesis: The colonic microbial environment correlates with bowel pathology and is relevant to development and progress of colorectal disease.
Research questions and outcomes:
In Phase 1 (year 1, hypothesis generating phase), the association between specific bacteria and the following diseases will be investigated: colorectal disease (colorectal cancer /polyps, adenomas (pre-cancerous lesions), inflammatory bowel disease (IBD) and diverticulosis).
Research questions:
- Is the microenvironment of the gut mucosa in and around tissue with adenomas/colorectal adenocarcinoma, IBD and diverticulosis colonized with a bacterial set different from healthy mucosa?
- Does age, sex and life/dietary habits impact different types of bacterial composition?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •All colonoscopy cases
排除标准
- •Not able to understand Swedish or to understand patientinformation
研究组 & 干预措施
Mucosal biopsies
Only blood samples and mucosal biopsies
干预措施: Mucosal tissue sampling (Genetic)
结局指标
主要结局
Bacterial diversity in colorectal disease
时间窗: 3 years
DNA sequencing on mucosal sampling
次要结局
未报告次要终点
研究者
Ulf Oskar Gustafsson, MD, PhD
Consultant Surgeon, associate professor
Karolinska Institutet
