<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660555</url>
  </required_header>
  <id_info>
    <org_study_id>METC 2011_026#C201136</org_study_id>
    <nct_id>NCT01660555</nct_id>
  </id_info>
  <brief_title>The Real Distribution of Microbiota Along the Colon Using a Novel Device Along the Colon Using a Novel Device</brief_title>
  <official_title>The Real Distribution of Microbiota Along the Colonic Mucosa Using a Novel Device Capable of Taking 'Protected' Biopsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The human microbiota forms a highly complex ecosystem with its host, consisting of hundreds&#xD;
      of different species of microorganisms, the majority of which have not yet been cultured.&#xD;
      With the recent advent of small subunit rRNA (SSU rRNA) gene sequencing technology, it is&#xD;
      estimated that the number of specific gastrointestinal tract phylotypes is more than 1800.&#xD;
      Sampling techniques might constitute a major confounder in the read-out of highly sensitive&#xD;
      techniques such as SSU-DNA analysis.&#xD;
&#xD;
      It is not properly established whether there is a difference in distribution of luminal&#xD;
      bacteria or mucosa adherent bacteria proximal or distal in the colon. In addition, 'bowel&#xD;
      lavage' before endoscopy might result in a disturbance of the microbiota in the bowel. For&#xD;
      this proof of concept study a novel device capable of taking 'protected' biopsies has been&#xD;
      designed.&#xD;
&#xD;
      We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal&#xD;
      to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to&#xD;
      show the real distribution of microbiota according to the localisation in the colon.&#xD;
&#xD;
      Furthermore, we hypothesize that microbial diversity will differ after bowel lavage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We hypothesize that the distribution of mucosal and luminal microbiota changes from proximal&#xD;
      to distal in the colon, and by taking 'protected biopsies' there will be the opportunity to&#xD;
      show the real distribution of microbiota according to the localisation in the colon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>at baseline colonoscopy, and if the colonoscopy will be repeated</time_frame>
    <description>'ill-prepared' patients will be included, biopsies will be taken at baseline colonoscopy.&#xD;
patients will be re-scheduled, and better prepared with laxatives for the 2nd colonoscopy: biospies will be taken again.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>at baseline colonoscopy, and if the colonoscopy will be repeated</time_frame>
    <description>'ill-prepared' patients will be included, biopsies will be taken at baseline colonoscopy.&#xD;
patients will be re-scheduled, and better prepared with laxatives for the 2nd colonoscopy: biospies will be taken again.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Patients Scheduled for Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Patiënts scheduled for colonoscopy</arm_group_label>
    <description>Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale &lt;3</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      mucosal biopsies will be screened for diversity by Denaturing Gradient Gel Electrophoresis of&#xD;
      16S rRNA genes and subsequently analysed with the HITChip.&#xD;
&#xD;
      (-&gt; DNA from microbiota instead of human DNA will be analysed)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        outpatients scheduled for colonoscopy for diagnostical purposes who are not known with&#xD;
        infectious enterocolitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale &lt;3&#xD;
&#xD;
          -  Sufficient indication to perform colonoscopy again&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Use of combination of two platelet aggregation inhibitors&#xD;
&#xD;
          -  Mandatory use of anti-coagulatory medication&#xD;
&#xD;
          -  Known history of hemostatic disorder&#xD;
&#xD;
          -  Use of systemic antibiotics in preceding 6 weeks&#xD;
&#xD;
          -  Use of probiotic or prebiotic treatment in preceding 6 weeks&#xD;
&#xD;
          -  Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia,&#xD;
             Campylobacter, enteropathogenic e coli)&#xD;
&#xD;
          -  History of surgery:&#xD;
&#xD;
               -  Resection of any part of the colon or Ileocoecal resection&#xD;
&#xD;
               -  Presence of an ileo- or colostoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CY Ponsioen, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic_Medical_Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>C.Y. Ponsioen</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Microbiota</keyword>
  <keyword>HITChip</keyword>
  <keyword>biopsies</keyword>
  <keyword>colon</keyword>
  <keyword>protected biopsies</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660555
org study id: METC 2011_026#C201136
nct id: NCT01660555
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Cross-Sectional
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
description: '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.
measure: 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
description: '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.
arm group label: Patiënts scheduled for colonoscopy
description: Ill prepared colon during index colonoscopy or sigmoidoscopy: Boston scale <3
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)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CY Ponsioen, MD PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: C.Y. Ponsioen
investigator title: MD PhD