Patients Scheduled for ColonoscopyNCT01660555
The Real Distribution of Microbiota Along the Colon Using a Novel Device Along the Colon Using a Novel Device
An observational study of Patients Scheduled for Colonoscopy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Scheduled for Colonoscopy
- How many people
- 10 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients scheduled for colonoscopy for diagnostical purposes who are not known with infectious enterocolitis.
Who may be able to join
- Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3
- Sufficient indication to perform colonoscopy again
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic medical Center
Amsterdam, 1100DD
Academic_Medical_Center
Amsterdam, 1100DD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Patients Scheduled for Colonoscopy
- Keywords
- Microbiota, HITChip, biopsies, colon, protected biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patiënts scheduled for colonoscopy | Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline colonoscopy, and if the colonoscopy will be repeated
Secondary outcomes (1)
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.
Measured: at baseline colonoscopy, and if the colonoscopy will be repeated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- CY Ponsioen, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660555
- Sponsor's protocol ID
- METC 2011_026#C201136
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies
- ClinicalTrials.gov ID
- NCT01660555
- Acronym / sponsor ID
- METC 2011_026#C201136
- Conditions
- Patients Scheduled for Colonoscopy
- Keywords
- Microbiota, HITChip, biopsies, colon, protected biopsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patiënts scheduled for colonoscopy | – | –Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients scheduled for colonoscopy for diagnostical purposes who are not known with infectious enterocolitis.
Key inclusion criteria (2 listed)
- Sufficient indication to perform colonoscopy again
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
Time frame: at baseline colonoscopy, and if the colonoscopy will be repeated
'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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CY Ponsioen, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Scheduled for Colonoscopy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.