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OpenTrials
Completed

NCT Number: NCT01660555

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

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.

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Key information

Conditions

Patients Scheduled for Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic medical Center, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2012
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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