<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/NCT03819803</url>
  </required_header>
  <id_info>
    <org_study_id>GI-aGvHD_01</org_study_id>
    <nct_id>NCT03819803</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation in aGvHD After ASCT</brief_title>
  <official_title>Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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>
      Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic&#xD;
      hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are&#xD;
      affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these&#xD;
      patients.&#xD;
&#xD;
      Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis&#xD;
      of various origin by infusion of the stool microbiota of a healthy donor into the&#xD;
      gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic&#xD;
      deployment of the donor microbiota into the patient´s caecum and terminal ileum.&#xD;
&#xD;
      Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic&#xD;
      colonic microbiota that can be attenuated by FMT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GI-aGvHD remission</measure>
    <time_frame>90 days after first FMT</time_frame>
    <description>Sustained remission of GI-aGvHD (CR or PR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GI-aGvHD remission</measure>
    <time_frame>45, 180 and 365 days after first FMT</time_frame>
    <description>Sustained remission of GI-aGvHD (CR or PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>180 and 365 days after first FMT</time_frame>
    <description>GI-aGvHD free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of GI-GvHD</measure>
    <time_frame>365 days after remission</time_frame>
    <description>Recurrence of GI-GvHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survival</measure>
    <time_frame>180 and 365 days after first FMT</time_frame>
    <description>Survival (death or alive)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SUSAR (Suspected Unexpected Serious Adverse Reaction)</measure>
    <time_frame>within 48 hours after a FMT</time_frame>
    <description>Number of lethal or non-lethal SUSAR's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SAE (Serious Adverse Event)</measure>
    <time_frame>within 48 hours after a FMT</time_frame>
    <description>Number of lethal or non-lethal SAE's</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Graft Versus Host Disease in GI Tract</condition>
  <arm_group>
    <arm_group_label>Steroid refractory GI-aGvHD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.&#xD;
Intervention: Fecal microbiota transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal microbiota transplantation</intervention_name>
    <description>200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum</description>
    <arm_group_label>Steroid refractory GI-aGvHD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first episode of histologically confirmed, steroid-refractory GI-aGvHD&#xD;
&#xD;
          -  reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA&#xD;
             measurement&#xD;
&#xD;
          -  eligibility for repeated colonoscopic procedures&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complications during a previous colonoscopy&#xD;
&#xD;
          -  recurrent episode of GI-aGvHD&#xD;
&#xD;
          -  lacking cardiopulmonary fitness for repeated colonoscopic procedures&#xD;
&#xD;
          -  septic infection&#xD;
&#xD;
          -  acute extraintestinal organ failure (excluding bone marrow)&#xD;
&#xD;
          -  mechanical ileus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Prof. Dr. Neumeister</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, Division of Hematology, Medical University of Graz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Walter DDr. Spindelboeck</last_name>
    <phone>0043 316 385 30195</phone>
    <email>walter.spindelboeck@medunigraz.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Spindelboeck, DDr.</last_name>
      <phone>0043316385</phone>
      <phone_ext>30195</phone_ext>
      <email>walter.spindelboeck@medunigraz.at</email>
    </contact>
    <investigator>
      <last_name>Walter Spindelboeck, DDr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Neumeister, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Högenauer, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</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>Graft vs Host Disease</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/NCT03819803
org study id: GI-aGvHD_01
nct id: NCT03819803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic
      hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are
      affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these
      patients.

      Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis
      of various origin by infusion of the stool microbiota of a healthy donor into the
      gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic
      deployment of the donor microbiota into the patient´s caecum and terminal ileum.

      Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic
      colonic microbiota that can be attenuated by FMT.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
primary purpose: Treatment
masking: None (Open Label)
measure: GI-aGvHD remission
time frame: 90 days after first FMT
description: Sustained remission of GI-aGvHD (CR or PR)
measure: GI-aGvHD remission
time frame: 45, 180 and 365 days after first FMT
description: Sustained remission of GI-aGvHD (CR or PR)
measure: Disease-free survival
time frame: 180 and 365 days after first FMT
description: GI-aGvHD free survival
measure: Recurrence of GI-GvHD
time frame: 365 days after remission
description: Recurrence of GI-GvHD
measure: Patient survival
time frame: 180 and 365 days after first FMT
description: Survival (death or alive)
measure: SUSAR (Suspected Unexpected Serious Adverse Reaction)
time frame: within 48 hours after a FMT
description: Number of lethal or non-lethal SUSAR's
measure: SAE (Serious Adverse Event)
time frame: within 48 hours after a FMT
description: Number of lethal or non-lethal SAE's
arm group label: Steroid refractory GI-aGvHD
arm group type: Experimental
description: Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.
Intervention: Fecal microbiota transplantation
intervention type: Biological
intervention name: Fecal microbiota transplantation
description: 200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum
arm group label: Steroid refractory GI-aGvHD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Peter Prof. Dr. Neumeister
role: Principal Investigator
affiliation: Department of Internal Medicine, Division of Hematology, Medical University of Graz
last name: Walter DDr. Spindelboeck
phone: 0043 316 385 30195
email: walter.spindelboeck@medunigraz.at
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Austria
responsible party type: Sponsor
mesh term: Graft vs Host Disease
sharing ipd: No