<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/NCT02245594</url>
  </required_header>
  <id_info>
    <org_study_id>MbCrohnRemission+Symp</org_study_id>
    <nct_id>NCT02245594</nct_id>
  </id_info>
  <brief_title>GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease</brief_title>
  <official_title>Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we would like to clarify the effect of long lasting Crohn's Disease on motility&#xD;
      of the gastrointestinal system in patient and the effect regarding sleep disturbances. This&#xD;
      will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica,&#xD;
      Schweiz) and the well known polysomnographic equipment.&#xD;
&#xD;
      Our hypothesises are:&#xD;
&#xD;
      Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have&#xD;
      abnormal colonic transit (primary endpoint).&#xD;
&#xD;
        1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms&#xD;
           have abnormal gastric emptying and small intestinal transit (secondary endpoints).&#xD;
&#xD;
        2. Total and segmental transit times found in patients with CD will be compared with&#xD;
           corresponding transit times in healthy volunteers found in a previous study.&#xD;
&#xD;
        3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.&#xD;
&#xD;
        4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or&#xD;
           colonic CD in remission and sleep disturbances.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total and segmental gastrointestinal transit time in patients suffering from CD</measure>
    <time_frame>Expected average total transit time less than two days, analyzed after 2-3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormal sleep pattern in patients with ileocoecal and/or colonic CD in remission</measure>
    <time_frame>Recorded during a single night, analyzed one of the two following days.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric emptying in CD patients</measure>
    <time_frame>Less than 1 day, analyzed after 1-3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small intestinal transit time in CD patients</measure>
    <time_frame>Less than 2 days, analyzed after 2-3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Segmental colonic transit time in CD patients</measure>
    <time_frame>Average less than 2 day, analyzed after 2-3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturnal basic colonic activity in patients with ileocoecal and/or colonic CD in remission and sleep disturbances</measure>
    <time_frame>Recorded during one night, analyzed one of the two following days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <condition>Sleep Disturbances</condition>
  <arm_group>
    <arm_group_label>Gl motility and sleep pattern</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A single blood sample (TNF-α, IL-1, IL-6) will be taken at the laboratory.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with quiescent Crohn's disease who still have gastrointestinal complaints.Found in&#xD;
        the out-patient clinic at Department V (Gastroenterology and Hepatology).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with CD based on accepted endoscopic and histological criteria (according to&#xD;
             ECCO guidelines (17) )&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  A minimum disease duration of five years&#xD;
&#xD;
          -  Remission defined by Faecal calprotectin &lt; 100 and CRP level within normal values for&#xD;
             a minimum of 1 month&#xD;
&#xD;
          -  Baseline values:&#xD;
&#xD;
               -  CRP normal&#xD;
&#xD;
               -  Faecal calprotectin &lt; 100&#xD;
&#xD;
          -  Ileocoecal and/or colic localization of disease (Montreal phenotype classification)&#xD;
&#xD;
          -  One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stricturizing CD&#xD;
&#xD;
          -  Obvious stenotic symptoms&#xD;
&#xD;
          -  Previous major gastrointestinal surgery&#xD;
&#xD;
          -  Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)&#xD;
&#xD;
          -  Medication altering gastrointestinal motility&#xD;
&#xD;
          -  Hepatobiliary disease (PSC)&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Metabolic disorder&#xD;
&#xD;
          -  Bacterial overgrowth (hydrogen breath test)&#xD;
&#xD;
          -  Planned MR scan in the four weeks following capsule intake (safety precaution)&#xD;
&#xD;
          -  Abdominal diameter &gt; 140 cm&#xD;
&#xD;
          -  Implanted electronic devices (pacemaker, ICD, etc.)&#xD;
&#xD;
          -  Diagnosed sleep disorder&#xD;
&#xD;
          -  Pregnancy and breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Krogh, MD, Dr. Med</last_name>
    <role>Study Director</role>
    <affiliation>Department of Gastroenterology and Hepatology, Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katrine O. Andersen</last_name>
    <phone>004542301641</phone>
    <email>koaaarhus@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aarhus University Hospital, Department of Gastroenterology and Hepatology</name>
      <address>
        <city>Aarhus C.</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <contact>
      <last_name>Katrine O. Andersen</last_name>
      <phone>004542301641</phone>
      <email>koaaarhus@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal motility</keyword>
  <keyword>Motility Tracking System (MTS)</keyword>
  <keyword>Transit time</keyword>
  <keyword>Sleep pattern</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <!-- 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/NCT02245594
org study id: MbCrohnRemission+Symp
nct id: NCT02245594
lead sponsor: 
has dmc: Yes
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility
      of the gastrointestinal system in patient and the effect regarding sleep disturbances. This
      will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica,
      Schweiz) and the well known polysomnographic equipment.

      Our hypothesises are:

      Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have
      abnormal colonic transit (primary endpoint).

        1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms
           have abnormal gastric emptying and small intestinal transit (secondary endpoints).

        2. Total and segmental transit times found in patients with CD will be compared with
           corresponding transit times in healthy volunteers found in a previous study.

        3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.

        4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or
           colonic CD in remission and sleep disturbances.
observational model: Cohort
time perspective: Prospective
measure: Total and segmental gastrointestinal transit time in patients suffering from CD
time frame: Expected average total transit time less than two days, analyzed after 2-3 days
measure: Abnormal sleep pattern in patients with ileocoecal and/or colonic CD in remission
time frame: Recorded during a single night, analyzed one of the two following days.
measure: Gastric emptying in CD patients
time frame: Less than 1 day, analyzed after 1-3 days
measure: Small intestinal transit time in CD patients
time frame: Less than 2 days, analyzed after 2-3 days
measure: Segmental colonic transit time in CD patients
time frame: Average less than 2 day, analyzed after 2-3 days
measure: Nocturnal basic colonic activity in patients with ileocoecal and/or colonic CD in remission and sleep disturbances
time frame: Recorded during one night, analyzed one of the two following days
arm group label: Gl motility and sleep pattern
A single blood sample (TNF-α, IL-1, IL-6) will be taken at the laboratory.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Klaus Krogh, MD, Dr. Med
role: Study Director
affiliation: Department of Gastroenterology and Hepatology, Aarhus University Hospital
last name: Katrine O. Andersen
phone: 004542301641
email: koaaarhus@gmail.com
facility: 
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
mesh term: Dyssomnias
mesh term: Parasomnias