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临床试验/NCT03302715
NCT03302715已完成不适用

KOLBIBAKT; The Association Between the Microbiological Environment in Colon and Colorectal Disease

Karolinska Institutet0 个研究点目标入组 1,257 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

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:

  1. 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?
  2. 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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulf Oskar Gustafsson, MD, PhD

Consultant Surgeon, associate professor

Karolinska Institutet

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