Patients Scheduled for Colonoscopy Clinical Trial
Official title:
The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
- 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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic medical Center | Amsterdam | |
| Netherlands | Academic_Medical_Center | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |