<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/NCT03812705</url>
  </required_header>
  <id_info>
    <org_study_id>SHSYXY-FMT-GVHD-2018002</org_study_id>
    <nct_id>NCT03812705</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD</brief_title>
  <acronym>FEMITGIGVHD</acronym>
  <official_title>Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the efficacy and safety of fecal microbiome&#xD;
      transplantation in patients with steroid resistant/dependent acute gastrointestinal&#xD;
      graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before&#xD;
      FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron&#xD;
      intravenously 1 hour before FMT. Patients will be injected 200~300 ml fecal microbiome fluid&#xD;
      to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's&#xD;
      condition is stable or improved within 1 week, second FMT may be performed 1 week later, up&#xD;
      to 4 times will be performed if patient response. If patient's condition is not improved&#xD;
      after the second FMT, ceasing FMT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of fecal microbiome&#xD;
      transplantation in patients with steroid resistant/dependent acute gastrointestinal&#xD;
      graft-versus-host disease (GVHD).&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Age&gt;= 14 yrs ≤60 yrs.&#xD;
&#xD;
        2. Diagnosed with hematological diseases.&#xD;
&#xD;
        3. Recipients of allogeneic peripheral blood stem cell transplantation.&#xD;
&#xD;
        4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100&#xD;
           days post-transplantation. The definition of steroid resistant/dependent acute&#xD;
           intestinal GVHD is progression within 3 days of starting treatment or an incomplete&#xD;
           response by 7 days or recurrence after initial dose reduction.&#xD;
&#xD;
        5. ECOG score ≤2;&#xD;
&#xD;
        6. signed consent form.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Complicated with uncontrolled severe infection except intestine and colon.&#xD;
&#xD;
        2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;&#xD;
&#xD;
        3. Absolute neutrophil count (ANC) &lt;0.5×10e9/L or platelet count (PLT) &lt; 20×10e9/L&#xD;
&#xD;
        4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure,&#xD;
           epilepsy or central nervous system dysfunction.&#xD;
&#xD;
        5. Participating other clinical trials.&#xD;
&#xD;
        6. Pregnant women.&#xD;
&#xD;
      Treatment:&#xD;
&#xD;
        1. Stop antibiotics treatment 1 day before FMT;&#xD;
&#xD;
        2. Fasting food 6 hours before FMT;&#xD;
&#xD;
        3. Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;&#xD;
&#xD;
        4. Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum&#xD;
           through duodenum tube by gastroscopy;&#xD;
&#xD;
        5. If patient's condition is stable or improved within 1 week, second FMT may be performed&#xD;
           1 week later, up to 4 times will be performed if patient response;&#xD;
&#xD;
        6. If patient's condition is not improved after the second FMT, stop FMT.&#xD;
&#xD;
      Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT,&#xD;
      including complete response and partial response.&#xD;
&#xD;
      Minor endpoints:&#xD;
&#xD;
        1. Time to response of acute gastrointestinal GVHD;&#xD;
&#xD;
        2. Duration of response of acute gastrointestinal GVHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response rate</measure>
    <time_frame>12 weeks within FMT</time_frame>
    <description>Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>12 weeks within FMT</time_frame>
    <description>Time to response of acute gastrointestinal GVHD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>12 weeks within FMT</time_frame>
    <description>Duration of response of acute gastrointestinal GVHD</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <arm_group>
    <arm_group_label>fecal microbiome transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;&#xD;
If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response;&#xD;
If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>fecal microbiome transplantation</intervention_name>
    <description>Stop antibiotics treatment 1 day before fecal microbiome transplantation;&#xD;
Fasting food 6 hours before fecal microbiome transplantation;&#xD;
Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;&#xD;
Perform fecal microbiome transplantation under colonoscopy or gastroscopy;&#xD;
Perform up to 4 times if patient response;&#xD;
Stop if no response after twice fecal microbiome transplantation.</description>
    <arm_group_label>fecal microbiome transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;= 14 yrs ≤60 yrs.&#xD;
&#xD;
          2. Diagnosed with hematological diseases.&#xD;
&#xD;
          3. Recipients of allogeneic peripheral blood stem cell transplantation.&#xD;
&#xD;
          4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within&#xD;
             100 days post-transplantation. The definition of steroid resistant/dependent acute&#xD;
             intestinal GVHD is progression within 3 days of starting treatment or an incomplete&#xD;
             response by 7 days or recurrence after initial dose reduction.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) score ≤2;&#xD;
&#xD;
          6. Signed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Complicated with uncontrolled severe infection except intestine and colon.&#xD;
&#xD;
          2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal&#xD;
             hemorrhage;&#xD;
&#xD;
          3. Absolute neutrophil count (ANC) &lt;0.5×10e9/L or platelet count (PLT) &lt; 20×10e9/L&#xD;
&#xD;
          4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure,&#xD;
             epilepsy or central nervous system dysfunction.&#xD;
&#xD;
          5. Participating other clinical trials.&#xD;
&#xD;
          6. Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liping Wan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liping Wan, MD</last_name>
    <phone>862137798075</phone>
    <email>wanliping924@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kun Zhou, MD</last_name>
    <phone>862137798987</phone>
    <email>zhkzhw@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Jiao Tong University Affilated First People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingpeng Wang, M.D, Ph.D</last_name>
      <phone>63069298</phone>
      <email>sfph_edu2@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yanhong Zhu, M.S</last_name>
      <phone>63240090</phone>
      <phone_ext>6213</phone_ext>
      <email>sfph_edu2@shmu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Liping Wan, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Jiao Tong University Affilated Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingpeng Wang, M.D, Ph.D</last_name>
      <phone>63069298</phone>
      <email>sfph_edu2@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yanhong Zhu, M.S</last_name>
      <phone>63240090</phone>
      <phone_ext>6213</phone_ext>
      <email>sfph_edu2@shmu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Liping Wan, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>万理萍</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <keyword>allogeneic hematopoeitic stem cell transplantation</keyword>
  <keyword>acute gastrointestinal graft versus host disease</keyword>
  <keyword>fecal microbiome transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</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/NCT03812705
org study id: SHSYXY-FMT-GVHD-2018002
nct id: NCT03812705
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome
      transplantation in patients with steroid resistant/dependent acute gastrointestinal
      graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before
      FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron
      intravenously 1 hour before FMT. Patients will be injected 200~300 ml fecal microbiome fluid
      to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's
      condition is stable or improved within 1 week, second FMT may be performed 1 week later, up
      to 4 times will be performed if patient response. If patient's condition is not improved
      after the second FMT, ceasing FMT.
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome
      transplantation in patients with steroid resistant/dependent acute gastrointestinal
      graft-versus-host disease (GVHD).

      Inclusion criteria:

        1. Age>= 14 yrs ≤60 yrs.

        2. Diagnosed with hematological diseases.

        3. Recipients of allogeneic peripheral blood stem cell transplantation.

        4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100
           days post-transplantation. The definition of steroid resistant/dependent acute
           intestinal GVHD is progression within 3 days of starting treatment or an incomplete
           response by 7 days or recurrence after initial dose reduction.

        5. ECOG score ≤2;

        6. signed consent form.

      Exclusion criteria:

        1. Complicated with uncontrolled severe infection except intestine and colon.

        2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;

        3. Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L

        4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure,
           epilepsy or central nervous system dysfunction.

        5. Participating other clinical trials.

        6. Pregnant women.

      Treatment:

        1. Stop antibiotics treatment 1 day before FMT;

        2. Fasting food 6 hours before FMT;

        3. Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;

        4. Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum
           through duodenum tube by gastroscopy;

        5. If patient's condition is stable or improved within 1 week, second FMT may be performed
           1 week later, up to 4 times will be performed if patient response;

        6. If patient's condition is not improved after the second FMT, stop FMT.

      Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT,
      including complete response and partial response.

      Minor endpoints:

        1. Time to response of acute gastrointestinal GVHD;

        2. Duration of response of acute gastrointestinal GVHD.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
primary purpose: Treatment
masking: None (Open Label)
measure: Response rate
time frame: 12 weeks within FMT
description: Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
measure: Time to response
time frame: 12 weeks within FMT
description: Time to response of acute gastrointestinal GVHD
measure: Duration of response
time frame: 12 weeks within FMT
description: Duration of response of acute gastrointestinal GVHD
arm group label: fecal microbiome transplantation
arm group type: Experimental
description: Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response;
If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.
intervention type: Biological
intervention name: fecal microbiome transplantation
description: Stop antibiotics treatment 1 day before fecal microbiome transplantation;
Fasting food 6 hours before fecal microbiome transplantation;
Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;
Perform fecal microbiome transplantation under colonoscopy or gastroscopy;
Perform up to 4 times if patient response;
Stop if no response after twice fecal microbiome transplantation.
arm group label: fecal microbiome transplantation
criteria: 
gender: All
minimum age: 14 Years
maximum age: 60 Years
healthy volunteers: No
last name: Liping Wan, MD
role: Principal Investigator
affiliation: Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal
last name: Liping Wan, MD
phone: 862137798075
email: wanliping924@hotmail.com
last name: Kun Zhou, MD
phone: 862137798987
email: zhkzhw@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: 万理萍
investigator title: Chief physician
mesh term: Hematologic Neoplasms