<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/NCT03256266</url>
  </required_header>
  <id_info>
    <org_study_id>intestinal organoids</org_study_id>
    <nct_id>NCT03256266</nct_id>
  </id_info>
  <brief_title>Effect of Antigens or Therapeutic Agents on in Vitro Human Intestinal Organoids</brief_title>
  <official_title>Establishment of Small Intestinal Human Organoids to Check the Influence of Nutrient Antigens or Therapeutic Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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>
      The study evaluates the effect of nutrient antigens or therapeutic agents on human small&#xD;
      intestinal organoids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The&#xD;
      organoids will be propagated and various antigens will be checked for their effects on&#xD;
      proliferation, production of inflammatory components or signal cascade.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, GLP-antagonist, or TNF antagonists</measure>
    <time_frame>baseline vs 24h vs 48h vs 72h</time_frame>
    <description>Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">375</enrollment>
  <condition>Intestine Disease</condition>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>healthy controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with allergy</arm_group_label>
    <description>patients with Food intolerances or Food allergy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>gastrointestinal disorders</arm_group_label>
    <description>patients with inflammatory bowel disease, irritable bowel disease, gluten sensitivity, short bowel syndrome</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        -Patients with patients with Food intolerances, Food allergy, intestinal disorders,&#xD;
        glutensensitivity, healthy controls who underwent a gastroduodenoscopy or coloscopy for&#xD;
        therapeutical intervention or screening&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with gastrointestinal disorders and therapeutical indication of&#xD;
             gastroduodenoscopy or coloscopy&#xD;
&#xD;
          -  healthy controls for preventive medical check-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yurdagül Zopf, Prof</last_name>
    <phone>49 9131 8545218</phone>
    <email>yurdaguel.zopf@uk-erlangen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Walburga Dieterich, PhD</last_name>
    <phone>49 9131 8535128</phone>
    <email>walburga.dieterich@gmx.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yurdaguel Zopf, Prof</last_name>
      <phone>49 9131 8545218</phone>
      <email>yurdaguel.zopf@uk-erlangen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03256266
org study id: intestinal organoids
nct id: NCT03256266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates the effect of nutrient antigens or therapeutic agents on human small
      intestinal organoids.
Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The
      organoids will be propagated and various antigens will be checked for their effects on
      proliferation, production of inflammatory components or signal cascade.
observational model: Cohort
time perspective: Prospective
measure: Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, GLP-antagonist, or TNF antagonists
time frame: baseline vs 24h vs 48h vs 72h
description: Determination of effects on organoids after antigen Stimulation with ELISA, histochemistry, RNA or proteome analysis
arm group label: healthy controls
description: healthy controls
arm group label: patients with allergy
description: patients with Food intolerances or Food allergy
arm group label: gastrointestinal disorders
description: patients with inflammatory bowel disease, irritable bowel disease, gluten sensitivity, short bowel syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yurdagül Zopf, Prof
phone: 49 9131 8545218
email: yurdaguel.zopf@uk-erlangen.de
last name: Walburga Dieterich, PhD
phone: 49 9131 8535128
email: walburga.dieterich@gmx.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Intestinal Diseases
sharing ipd: No