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临床试验/NCT02726243
NCT02726243已完成不适用

Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
1
主要终点
Composition of fecal microbiota by 16S sequencing

研究概览

简要总结

Build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).

详细描述

Inflammatory bowel disease (IBD) are chronic and relapsing disabling disease. Crohn's disease (CD) and Ulcerative colitis (UC) are the two main types of IBD.

Patients with IBD are at greater risk of intestinal infection including viral infections (including cytomegalovirus) and bacterial (especially Clostridium difficile). In the long term, patients with colonic involvement are at an increased risk of colorectal cancer (CRC). Moreover, it has been reported in several cohort studies that patients with primary sclerosing cholangitis (PSC) associated with IBD (PSC-IBD), have an even increased risk of CRC (about 10 to 20% at 10 years). Other studies also suggest that the microbiota has an impact on liver diseases. Conversely, cholestatic liver diseases (such as PSC) can influence the microbiota, notably through modification of the production of bile acids. Finally, the role of the gut microbiota in the development of the CRC in IBD has been well established in animal models. The pathophysiological mechanisms are not well understood but may involve an alteration of the balance between protective bacteria against harmful microbiota.

This study aims to investigate the link between gut microbiota, intestinal inflammation, colorectal cancer, bile acid and liver diseases and this, through the creation of a biological collection of fecal microbiota from fecal samples from 8 groups of subjects: (i) IBD without CCR (ii) IBD with CCR, (iii) IBD with dysplasia, (iv) non IBD without CCR, (v) non IBD with CCR, (vi) IBD-CSP without CCR, (vii ) IBD-CSP with CCR, (viii) IBD-CSP with dysplasia. In these patients, microbiota composition will be assessed by sequencing technology.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patient with the capacity to give informed consent.
  • Age ≥ 18 years.
  • A patient with IBD (Crohn's disease or ulcerative colitis) or healthy subject having a screening colonoscopy scheduled.
  • Diagnosis of pathologies in question established or confirmed in any of the services involved in the study and according to international diagnostic criteria (Consensus ECCO).
  • Patient follow-up in one of the services involved in the study

排除标准

  • trusteeship, guardianship or safeguard justice.
  • Subject does not speak French.
  • Subject unable to answer questions or to speak.
  • Previous history of colonic resection
  • Taking antibiotics within 8 weeks preceding the stool sample Temporary exclusion criterium)
  • Taking a bowel preparation for colonoscopy within 6 weeks before the stool sample (temporary exclusion criterium). Sampling is possible before bowel preparation or on the first stool after starting the bowel preparation.
  • Ostomy at the time of sampling
  • Current treatment by radiotherapy, chemotherapy

结局指标

主要结局

Composition of fecal microbiota by 16S sequencing

时间窗: Baseline

Microbiota composition will be assessed using MiSeq technology

次要结局

  • Profile of fecal bile acids(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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