<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/NCT03270267</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3035_MICI School</org_study_id>
    <nct_id>NCT03270267</nct_id>
  </id_info>
  <brief_title>Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism</brief_title>
  <acronym>MICI School</acronym>
  <official_title>Chronic Inflammatory Bowel Diseases and School Absenteeism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Study of the causes and rate of school absenteeism in children and adolescents with&#xD;
      Inflammatory Bowel Disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days of absence from school due to IBD</measure>
    <time_frame>Month 10</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled</measure>
    <time_frame>Month 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study of repercussion of the number of days of absence due to IBD on school results</measure>
    <time_frame>Month 10</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Patients with IBD</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <arm_group_label>Patients with IBD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with IBD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child aged 6 to 18 years old&#xD;
&#xD;
          -  Child with definite diagnosis of IBD for at least 6 months&#xD;
&#xD;
          -  Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at&#xD;
             least 2 annual consultations)&#xD;
&#xD;
          -  Non-opposition of the child and the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  School leaving&#xD;
&#xD;
          -  Student at the University&#xD;
&#xD;
          -  Other serious disease outside IBD preventing normal schooling&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03270267
org study id: 35RC16_3035_MICI School
nct id: NCT03270267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of the causes and rate of school absenteeism in children and adolescents with
      Inflammatory Bowel Disease.
observational model: Case-Only
time perspective: Prospective
measure: Number of days of absence from school due to IBD
time frame: Month 10
measure: Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled
time frame: Month 10
measure: Study of repercussion of the number of days of absence due to IBD on school results
time frame: Month 10
arm group label: Patients with IBD
intervention type: Other
intervention name: Questionnaires
arm group label: Patients with IBD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases