MedPath

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

Completed
Conditions
Patients Scheduled for Colonoscopy
Registration Number
NCT01660555
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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' situationat 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.

Secondary Outcome Measures
NameTimeMethod
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

'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.

Trial Locations

Locations (2)

Academic_Medical_Center

🇳🇱

Amsterdam, Netherlands

Academic medical Center

🇳🇱

Amsterdam, Netherlands

© Copyright 2025. All Rights Reserved by MedPath