<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/NCT03244254</url>
  </required_header>
  <id_info>
    <org_study_id>SchneiderCMCIsraelIFABP</org_study_id>
    <nct_id>NCT03244254</nct_id>
  </id_info>
  <brief_title>Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients</brief_title>
  <official_title>I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schneider Children's Medical Center, Israel</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>
      A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac&#xD;
      patients during diagnosis to levels under gluten free diet, it's correlation with traditional&#xD;
      serology testing and questionnaire regarding patient responsiveness to the gluten free diet,&#xD;
      and in comparison to a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly&#xD;
      than traditional serology to enterocyte injury in celiac patients who do not a gluten free&#xD;
      diet. In this study a pediatric population of celiac patients will be tested for I-FABP&#xD;
      levels during initial endoscopic diagnosis and during one year of follow up. Their levels&#xD;
      will be compared to a control group of pediatric patients undergoing endoscopy for reasons&#xD;
      other than suspicion of celiac disease. During the period of follow up, the test group will&#xD;
      undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for&#xD;
      serology in celiac patients and a questionnaire regarding. The results will be analyzed in&#xD;
      the hope of finding a way to use I-FABP as a more direct, accurate marker of disease&#xD;
      activity, and of correlations between it's level and the patient's Marsh score at diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>I-FABP levels at diagnosis</measure>
    <time_frame>1 day of enrollment</time_frame>
    <description>Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>I-FABP levels during remission</measure>
    <time_frame>6 months &amp; 12 months after enrollment</time_frame>
    <description>Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Celiac Disease in Children</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <description>Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients undergoing endoscopy at the research hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology&#xD;
             (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel&#xD;
             disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver&#xD;
             malignancy.&#xD;
&#xD;
          -  Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months&#xD;
&#xD;
          -  NSAID use in the last week.&#xD;
&#xD;
          -  Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.&#xD;
&#xD;
          -  Known genetic disorders (such as Down's syndrome).&#xD;
&#xD;
          -  Patients whose TTG was elevated but lower than 3 times the normal range.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raanan Shamir, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Assaf Hoofien, Dr.</last_name>
    <phone>972523310096</phone>
    <email>Laerites@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raanan Shamir, Prof.</last_name>
    <email>RaananS@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petaẖ Tiqwa</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Assafh Hoofien, Dr.</last_name>
      <phone>9720523310096</phone>
      <email>Laerites@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schneider Children's Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Dr. Assaf Hoofien</investigator_full_name>
    <investigator_title>Research fellow</investigator_title>
  </responsible_party>
  <keyword>Celiac Disease</keyword>
  <keyword>Children</keyword>
  <keyword>I-FABP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</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/NCT03244254
org study id: SchneiderCMCIsraelIFABP
nct id: NCT03244254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac
      patients during diagnosis to levels under gluten free diet, it's correlation with traditional
      serology testing and questionnaire regarding patient responsiveness to the gluten free diet,
      and in comparison to a control group.
I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly
      than traditional serology to enterocyte injury in celiac patients who do not a gluten free
      diet. In this study a pediatric population of celiac patients will be tested for I-FABP
      levels during initial endoscopic diagnosis and during one year of follow up. Their levels
      will be compared to a control group of pediatric patients undergoing endoscopy for reasons
      other than suspicion of celiac disease. During the period of follow up, the test group will
      undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for
      serology in celiac patients and a questionnaire regarding. The results will be analyzed in
      the hope of finding a way to use I-FABP as a more direct, accurate marker of disease
      activity, and of correlations between it's level and the patient's Marsh score at diagnosis.
observational model: Cohort
time perspective: Prospective
measure: I-FABP levels at diagnosis
time frame: 1 day of enrollment
description: Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
measure: I-FABP levels during remission
time frame: 6 months & 12 months after enrollment
description: Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)
arm group label: Test Group
description: Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher.
arm group label: Control Group
description: Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Raanan Shamir, Prof
role: Study Director
affiliation: Director
last name: Assaf Hoofien, Dr.
phone: 972523310096
email: Laerites@gmail.com
last name: Raanan Shamir, Prof.
email: RaananS@clalit.org.il
facility: 
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Schneider Children's Medical Center, Israel
investigator full name: Dr. Assaf Hoofien
investigator title: Research fellow
mesh term: Celiac Disease