The Real Distribution of Microbiota Along the Colon Using a Novel Device Along the Colon Using a Novel Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies

Conditions
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Patients Scheduled for Colonoscopy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3 Sufficient indication to perform colonoscopy again Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patiënts scheduled for colonoscopy<br>Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | '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. | at baseline colonoscopy, and if the colonoscopy will be repeated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | '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. | at baseline colonoscopy, and if the colonoscopy will be repeated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, HITChip, biopsies, colon, protected biopsies