<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/NCT03763487</url>
  </required_header>
  <id_info>
    <org_study_id>Indicators of celiac activity</org_study_id>
    <nct_id>NCT03763487</nct_id>
  </id_info>
  <brief_title>The Aim of This Project is to Verify Whether a Depletion of B Cell Memory Subpopulation (&quot;Marginal-zone-like&quot;) CD19 + IgD + CD27 + and CD19 + IgM + CD27 + is a Useful Indicator of Hyposplenism in Patients With Celiac Disease</brief_title>
  <official_title>Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Hradec Kralove</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Hradec Kralove</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is expected to confirm the hypothesis that hyposplenism in patients with celiac&#xD;
      disease is not conditioned by a selective memory deficiency of B lymphocytes.&#xD;
&#xD;
      Other objectives of project are:&#xD;
&#xD;
        -  determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to&#xD;
           gluten-free diet&#xD;
&#xD;
        -  determination of citrulline in plasma as an indicator of the overall functional capacity&#xD;
           enterocytes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound examination is focused to spleen size (spleen volumetry). Methodology of&#xD;
      laboratory examinations is based on venous blood sampling for the determination of memory&#xD;
      B-like marginal zone by flow cytometry; gliadin 33-mer (ELISA) determination in faecal and&#xD;
      urine sample; blood plasma extraction for citrulline (high performance liquid chromatography,&#xD;
      HPLC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>50 patients and 30 healthy blood donor</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>concentration of B-lymphocytes as parameter to evaluate treatment effect</measure>
    <time_frame>one year</time_frame>
    <description>assessment method: blood sampling, units: the measurement results are in absolute numbers, method: flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>concentration of B-lymphocytes as parameter to evaluate treatment effect</measure>
    <time_frame>one year</time_frame>
    <description>assessment method: blood sampling, units: the measurement results are in percentage numbers, method: flow cytometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>concentration of citrullin in plasma as parameter to evaluate treatment effect</measure>
    <time_frame>one year</time_frame>
    <description>assessment method: blood sampling, units: μmol/l (micromol/l; Citrullin cut-off for intestinal failure is &lt;20μmol / L), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>concentration of ornithin in plasma as parameter to evaluate treatment effect</measure>
    <time_frame>one year</time_frame>
    <description>assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy blood donors</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>venous blood sampling</intervention_name>
    <description>Venous blood samples to determine memory B lymphocytes.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spleen volumetry</intervention_name>
    <description>Ultrasound examination of spleen to scaled the size.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed celiac disease&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  haematological diseases and cancer&#xD;
&#xD;
          -  infectious and non-infectious inflammation of the small intestine&#xD;
&#xD;
          -  congenital or acquired immunodeficiency&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  immunosuppressant treatment&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  pregnancy and lactation&#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_contact>
    <last_name>Ladislav Douda, M.D.</last_name>
    <phone>495 83 4240</phone>
    <email>ladislav.douda@fnhk.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Hradec Králové</name>
      <address>
        <city>Hradec Králové</city>
        <state>The Czech Republic</state>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ladislav Douda, M.D.</last_name>
      <phone>495 83 4240</phone>
      <email>ladislav.douda@fnhk.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1419299/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/18270242</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415212/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/11113071</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Hradec Kralove</investigator_affiliation>
    <investigator_full_name>Proff. Jan Bures, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03763487
org study id: Indicators of celiac activity
nct id: NCT03763487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project is expected to confirm the hypothesis that hyposplenism in patients with celiac
      disease is not conditioned by a selective memory deficiency of B lymphocytes.

      Other objectives of project are:

        -  determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to
           gluten-free diet

        -  determination of citrulline in plasma as an indicator of the overall functional capacity
           enterocytes
Ultrasound examination is focused to spleen size (spleen volumetry). Methodology of
      laboratory examinations is based on venous blood sampling for the determination of memory
      B-like marginal zone by flow cytometry; gliadin 33-mer (ELISA) determination in faecal and
      urine sample; blood plasma extraction for citrulline (high performance liquid chromatography,
      HPLC).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 patients and 30 healthy blood donor
primary purpose: Diagnostic
masking: None (Open Label)
measure: concentration of B-lymphocytes as parameter to evaluate treatment effect
time frame: one year
description: assessment method: blood sampling, units: the measurement results are in absolute numbers, method: flow cytometry
measure: concentration of B-lymphocytes as parameter to evaluate treatment effect
time frame: one year
description: assessment method: blood sampling, units: the measurement results are in percentage numbers, method: flow cytometry
measure: concentration of citrullin in plasma as parameter to evaluate treatment effect
time frame: one year
description: assessment method: blood sampling, units: μmol/l (micromol/l; Citrullin cut-off for intestinal failure is <20μmol / L), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)
measure: concentration of ornithin in plasma as parameter to evaluate treatment effect
time frame: one year
description: assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)
arm group label: Patients
arm group type: Experimental
description: Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
arm group label: healthy blood donors
arm group type: No Intervention
description: No intervention in this group.
intervention type: Diagnostic Test
intervention name: venous blood sampling
description: Venous blood samples to determine memory B lymphocytes.
arm group label: Patients
intervention type: Procedure
intervention name: spleen volumetry
description: Ultrasound examination of spleen to scaled the size.
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ladislav Douda, M.D.
phone: 495 83 4240
email: ladislav.douda@fnhk.cz
facility: 
status: Recruiting
contact: 
country: Czechia
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1419299/
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/18270242
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415212/
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/11113071
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University Hospital Hradec Kralove
investigator full name: Proff. Jan Bures, MD
investigator title: Principal Investigator
mesh term: Celiac Disease
sharing ipd: Undecided