Clinical trial NCT01660555: The Real Distribution of Microbiota Along the Colon Using a Novel Device Along the Colon Using a Novel Device
Official title: The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Scheduled for Colonoscopy
Keywords: Microbiota
HITChip
biopsies
colon
protected biopsies
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: outpatients scheduled for colonoscopy for diagnostical purposes who are not known with infectious enterocolitis.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: 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
timeFrame: at baseline colonoscopy, and if the colonoscopy will be repeated
Secondary outcomes:
measure: 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.
timeFrame: at baseline colonoscopy, and if the colonoscopy will be repeated
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic medical Center
city: Amsterdam
country: Netherlands
facility: Academic_Medical_Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: CY Ponsioen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: