The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Intra-individual differences in phylogenetic fingerprinting and phylotype quantification from mucosal and faecal biopsy samples located at the colon ascendens and the sigmoid both in an 'ill prepared' as well as in a 'well-prepared' situation
研究概览
简要总结
The human microbiota forms a highly complex ecosystem with its host, consisting of hundreds of different species of microorganisms, the majority of which have not yet been cultured. With the recent advent of small subunit rRNA (SSU rRNA) gene sequencing technology, it is estimated that the number of specific gastrointestinal tract phylotypes is more than 1800. Sampling techniques might constitute a major confounder in the read-out of highly sensitive techniques such as SSU-DNA analysis.
It is not properly established whether there is a difference in distribution of luminal bacteria or mucosa adherent bacteria proximal or distal in the colon. In addition, 'bowel lavage' before endoscopy might result in a disturbance of the microbiota in the bowel. For this proof of concept study a novel device capable of taking 'protected' biopsies has been designed.
We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to show the real distribution of microbiota according to the localisation in the colon.
Furthermore, we hypothesize that microbial diversity will differ after bowel lavage.
详细描述
We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to show the real distribution of microbiota according to the localisation in the colon.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3
- •Sufficient indication to perform colonoscopy again
排除标准
- •Inability to give informed consent
- •Life expectancy < 12 months
- •Use of combination of two platelet aggregation inhibitors
- •Mandatory use of anti-coagulatory medication
- •Known history of hemostatic disorder
- •Use of systemic antibiotics in preceding 6 weeks
- •Use of probiotic or prebiotic treatment in preceding 6 weeks
- •Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
- •History of surgery:
- •Resection of any part of the colon or Ileocoecal resection
- •Presence of an ileo- or colostoma
结局指标
主要结局
Intra-individual differences in phylogenetic fingerprinting and phylotype quantification from mucosal and faecal biopsy samples located at the colon ascendens and the sigmoid both in an 'ill prepared' as well as in a 'well-prepared' situation
时间窗: at baseline colonoscopy, and if the colonoscopy will be repeated
'ill-prepared' patients will be included, biopsies will be taken at baseline colonoscopy. patients will be re-scheduled, and better prepared with laxatives for the 2nd colonoscopy: biospies will be taken again.
次要结局
- Intra-individual differences in phylogenetic fingerprinting and phylotype quantification from mucosal and faecal biopsy samples located at the colon ascendens and sigmoid using 'protected' biopsy material versus 'un-protected' material.(at baseline colonoscopy, and if the colonoscopy will be repeated)
研究者
C.Y. Ponsioen
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)