<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/NCT02255617</url>
  </required_header>
  <id_info>
    <org_study_id>47057</org_study_id>
    <nct_id>NCT02255617</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study</brief_title>
  <official_title>A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in&#xD;
      cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance&#xD;
      therapy with lactulose and/or rifaximin or metronidazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4.&#xD;
      HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2014</start_date>
  <completion_date type="Actual">September 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 25, 2019</primary_completion_date>
  <phase>Phase 1/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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Portion of participants with normailzation of ICT or Stroop Test during the study</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum ammonia level pre and post FMT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Intestinal Microbiota pre and post FMT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>8 weeks</time_frame>
    <description>All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following:&#xD;
i) Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results.&#xD;
iv) Possible infections as defined by i) fever (temp &gt; 37.80 C), ii) leukocytosis (&gt;15,000 mm3) or increased immature neutrophils in blood (&gt;500 mm3), negative cultures and no other signs of infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in stool bile acids composition pre and post FMT</measure>
    <time_frame>8 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in stool short chain fatty acids pre and post FMT</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Hepatic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Fecal Microbiota Transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplant</intervention_name>
    <description>Fecal transplant processed from routinely screened universal donors</description>
    <arm_group_label>Fecal Microbiota Transplant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adult (age &gt; 18 years of age) cirrhotic patients of various etiology, on lactulose&#xD;
             and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis&#xD;
&#xD;
          2. abnormal inhibitory control test, defined as greater than 5 lures.&#xD;
&#xD;
          3. an infectious etiology which may cause HE has been ruled out&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. those with tense ascites&#xD;
&#xD;
          2. those who do not provide assent&#xD;
&#xD;
          3. those who are judged to have a life expectancy of less than 3 months,&#xD;
&#xD;
          4. those who had TIPS within 3 months,&#xD;
&#xD;
          5. those with neurologic diseases such as dementia, Parkinson's disease, and structural&#xD;
             brain lesions&#xD;
&#xD;
          6. pregnancy&#xD;
&#xD;
          7. those with intestinal obstruction&#xD;
&#xD;
          8. those with alcoholic hepatitis&#xD;
&#xD;
          9. those with active alcohol or substance abuse&#xD;
&#xD;
         10. those without stable social support&#xD;
&#xD;
         11. those who have a concurrent infection, such as SBP, pneumonia or UTI&#xD;
&#xD;
         12. those with creatinine clearance less than 50% compared to baseline&#xD;
&#xD;
         13. those with recent hospital admission, defined as within one month of enrollment, for&#xD;
             hepatic encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Dina Kao</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatic Encephalopathy</mesh_term>
    <mesh_term>Brain 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/NCT02255617
org study id: 47057
nct id: NCT02255617
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in
      cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance
      therapy with lactulose and/or rifaximin or metronidazole.
Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4.
      HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Portion of participants with normailzation of ICT or Stroop Test during the study
time frame: 8 weeks
measure: Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
time frame: 8 weeks
measure: Changes in serum ammonia level pre and post FMT
time frame: 8 weeks
measure: Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
time frame: 8 weeks
measure: Changes in Intestinal Microbiota pre and post FMT
time frame: 8 weeks
measure: Serious Adverse Events
time frame: 8 weeks
description: All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following:
i) Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results.
iv) Possible infections as defined by i) fever (temp > 37.80 C), ii) leukocytosis (>15,000 mm3) or increased immature neutrophils in blood (>500 mm3), negative cultures and no other signs of infection.
measure: Changes in stool bile acids composition pre and post FMT
time frame: 8 Weeks
measure: Changes in stool short chain fatty acids pre and post FMT
time frame: 8 weeks
arm group label: Fecal Microbiota Transplant
arm group type: Experimental
description: Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
intervention type: Biological
intervention name: Fecal Microbiota Transplant
description: Fecal transplant processed from routinely screened universal donors
arm group label: Fecal Microbiota Transplant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Dina Kao
investigator title: Assistant Professor
mesh term: Hepatic Encephalopathy
mesh term: Brain Diseases