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

This study is currently recruiting participants.
Verified August 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01660555
First received: August 6, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Patients Scheduled for Colonoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    '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:
  • 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 ] [ Designated as safety issue: No ]

    '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.



Biospecimen Retention:   Samples With DNA

mucosal biopsies will be screened for diversity by Denaturing Gradient Gel Electrophoresis of 16S rRNA genes and subsequently analysed with the HITChip.

(-> DNA from microbiota instead of human DNA will be analysed)


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patiënts scheduled for colonoscopy
Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

outpatients scheduled for colonoscopy for diagnostical purposes who are not known with infectious enterocolitis.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660555

Contacts
Contact: C Ponsioen, MD PhD +31205666012 c.y.ponsioen@amc.uva.nl
Contact: NGM Rossen, PhD student +31205662199 n.g.rossen@amc.uva.nl

Locations
Netherlands
Academic_Medical_Center Recruiting
Amsterdam, Netherlands, 1100DD
Contact: C Y Ponsioen, MD PhD     +31-205666012     c.y.ponsioen@amc.uva.nl    
Contact: NGM Rossen, PhD student     +3120-5662199     n.g.rossen@amc.uva.nl    
Principal Investigator: C Y Ponsioen, Md PhD            
Academic medical Center Recruiting
Amsterdam, Netherlands, 1100DD
Contact: C Ponsioen, MD PhD     +3120-5666012     c.y.ponsioen@amc.uva.nl    
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: CY Ponsioen, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: C.Y. Ponsioen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01660555     History of Changes
Other Study ID Numbers: METC 2011_026#C201136
Study First Received: August 6, 2012
Last Updated: August 6, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Microbiota
HITChip
biopsies
colon
protected biopsies

ClinicalTrials.gov processed this record on May 23, 2013