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

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.

Study Overview

• Status: Completed
• Conditions: Patients Scheduled for Colonoscopy

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1100DD
    • Academic_Medical_Center
  • Amsterdam, Netherlands, 1100DD
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patiënts scheduled for colonoscopy; Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: CY Ponsioen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: September 1, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Microbiota; colon; biopsies; HITChip; protected biopsies
• Other Study ID Numbers: METC 2011_026#C201136