Completed

The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 2012
See protocol details

Summary

Principal SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last updated: September 3, 2014
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Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last updated: September 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Academic medical Center

Amsterdam, NetherlandsOpen Academic medical Center in Google Maps

Academic_Medical_Center

Amsterdam, Netherlands
Completed2 Study Centers