Primary Objective: to show the differences in distribution of microbial DNA proximal versus distal in the colon as well as luminal composition versus mucosa adherent. Secondary Objective: to test whether bowel lavage has influence on the microbial…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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
Secondary outcome
• Intra-individual differences in phylogenetic fingerprinting and phylotype
quantification from mucosal and fecal biopsy samples located at the colon
ascendens and sigmoid using *protected* biopsy material versus *un-protected*
material.
Background 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 now estimated that the cumulative number of
specific gastrointestinal tract phylotypes is more than 1800, of which less
than 25% can be identified with culture dependent approaches. 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. Moreover, sampling techniques might constitute a major
confounder in the read-out of highly sensitive techniques such as SSU-DNA
analysis.
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.
Study objective
Primary Objective: to show the differences in distribution of microbial DNA
proximal versus distal in the colon as well as luminal composition versus
mucosa adherent.
Secondary Objective: to test whether bowel lavage has influence on the
microbial distribution in the bowel.
Study design
This is a proof of concept genuine exploratory study
Study burden and risks
There will be no direct benefit associated with participation.
The only extra risk associated to this protocol pertains to the extra biopsies.
Biopsy sampling during colonoscopy is very safe. The only risk associated with
this procedure is post biopsy bleeding. Significant bleeding as a result of
taking biopsies is very rare.
Postbus 22600
1100 DD Amsterdam
NL
Postbus 22600
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Boston scale <3 during colonoscopy
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:
oResection of any part of the colon or Ileocoecal resection
oPresence of an ileo- or colostoma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35517.018.11 |