<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/NCT03796598</url>
  </required_header>
  <id_info>
    <org_study_id>GAST-001-18S</org_study_id>
    <secondary_id>CX001076</secondary_id>
    <nct_id>NCT03796598</nct_id>
  </id_info>
  <brief_title>FMT in Cirrhosis and Hepatic Encephalopathy</brief_title>
  <official_title>Fecal Microbiota Transplant in Veterans With Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with end stage of liver disease or cirrhosis can develop confusion due to high&#xD;
      ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the&#xD;
      bowels and may not respond to current standard of care treatments. Repeated episodes of&#xD;
      confusion can make it difficult for patients to function and may result in multiple&#xD;
      admissions to the hospital and burden on the family. The investigators have studied using a&#xD;
      healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in&#xD;
      small studies with good results. In this trial the investigators propose to perform these&#xD;
      procedures using an upper and lower route in Veterans who suffer from this condition and&#xD;
      follow them for safety and hospitalizations over 6 months. The investigators will compare&#xD;
      this to placebo treatments and hope that this intervention can improve the health and daily&#xD;
      functioning of affected patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Indication: Cirrhosis and hepatic encephalopathy&#xD;
&#xD;
      Study Objectives: To evaluate the safety and tolerability of fecal transplant in patients&#xD;
      with cirrhosis and hepatic encephalopathy&#xD;
&#xD;
      Rationale and Supporting Evidence:&#xD;
&#xD;
      Hepatic encephalopathy affects 30-45% of patients with cirrhosis and adversely affects&#xD;
      survival in these patients. The mainstay of treatment for hepatic encephalopathy (HE) has&#xD;
      long been the manipulation of the gut flora through antibiotics, prebiotics or probiotics.&#xD;
      The current first and second line therapies for HE in the US are lactulose and rifaximin&#xD;
      respectively that uniquely act within the confines of the gut lumen with encouraging clinical&#xD;
      results. However, there is a subset of patients with HE that continues to recur despite being&#xD;
      on both treatments. This patient group is at a higher risk of poor outcomes because HE has&#xD;
      now been removed from liver transplant priority and multiple episodes of HE can result in&#xD;
      cumulative brain injury which may be irreversible. Therefore, the prevention of recurrent HE&#xD;
      is an important therapeutic goal.&#xD;
&#xD;
      The investigators' group and other reports have shown that patients with HE and cirrhosis are&#xD;
      more likely to have overgrowth of potentially pathogenic bacterial taxa such as&#xD;
      Enterobacteriaceae and reduction of autochthonous species such as Lachnospiraceae and&#xD;
      Ruminococcaceae in the stool and the colonic mucosa. This has been linked to poor performance&#xD;
      on cognitive tests that are a hallmark of HE and with increased systemic inflammation in&#xD;
      these patients.&#xD;
&#xD;
      Therefore, a gut-based therapeutic option that can potentially improve the recurrence rate&#xD;
      and the overall prognosis is needed. Fecal transplant has been shown to be effective in&#xD;
      conditions with predominant gut-bacterial overgrowth or alteration such as recurrent&#xD;
      Clostridium difficile and inflammatory bowel disease. Safe protocols have been developed&#xD;
      across the world and studies are being performed in the US under FDA-monitored INDs.&#xD;
      Limitations to performing fecal transplant include identifying and screening appropriate&#xD;
      donors, which is time consuming and costly, with the cost typically falling to the patient or&#xD;
      donor as the required screening is generally not covered by insurance.&#xD;
&#xD;
      The investigators' preliminary data suggest that a one-time administration of an FMT-enema&#xD;
      using a rationally-selected donor is safe in patients with cirrhosis and recurrent HE.&#xD;
      However, given the small bowel overgrowth and the predominantly small bowel location for&#xD;
      bacterial translocation in cirrhosis, which is out of the reach of an enema, an upper GI&#xD;
      route for FMT needs to be explored. In the investigators' published experience, a single&#xD;
      enema from a rationally-derived donor was associated with significantly lower total and&#xD;
      HE-related hospitalizations compared to patients who were randomized to standard of care,&#xD;
      with a stable long-term course over &gt;1 year. The investigators' data show that FMT was&#xD;
      associated with favorable changes in fecal bile acid (BA) profile with a decrease in&#xD;
      proportions of fecal secondary BAs, conjugated BAs and increase in sulfated BAs, indicating a&#xD;
      healthier milieu. The investigators also have preliminary data defining the safety of oral&#xD;
      FMT capsules in patients with cirrhosis and HE in a current trial led by us. The use of&#xD;
      combined oral and rectal routes of FMT, which can potentially alleviate both small bowel and&#xD;
      colonic translocation are likely to be better than either alone.&#xD;
&#xD;
      Overall aim: To determine the effect of dual oral and rectal administration of FMT from a&#xD;
      rational donor on clinical outcomes (hospitalizations, brain function, quality of life) and&#xD;
      host-microbiota interactions (microbial composition and bile acid composition with systemic&#xD;
      and intestinal inflammation), compared to single route of administration and placebo, along&#xD;
      with a second oral capsular FMT vs placebo administration in cirrhotic patients with HE using&#xD;
      a randomized, phase II clinical trial.&#xD;
&#xD;
      Design overview: Four groups of outpatients with cirrhosis will be randomized using random&#xD;
      sequence generator into placebo and FMT groups and followed for 6 months under an FDA IND&#xD;
      double-blind clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 24, 2024</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be divided into 4 groups via randomization&#xD;
Group 1: Dual oral and rectal FMT, Group 2: Oral FMT and rectal placebo, Group 3: Oral placebo and rectal FMT and Group 4: Oral and rectal placebo</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serious adverse events related to FMT</measure>
    <time_frame>6 months</time_frame>
    <description>Number of serious adverse events between groups related to FMT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to FMT</measure>
    <time_frame>6 months</time_frame>
    <description>Number of adverse events that do not fit the criteria of serious adverse events between groups related to FMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbial diversity in stool</measure>
    <time_frame>6 months</time_frame>
    <description>Shannon diversity index compared to baseline and engraftment related to the donor at baseline, within 30 days and then monthly till 6 months. Ranges usually from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sickness Impact Profile change</measure>
    <time_frame>30 days and 6 months</time_frame>
    <description>Quality of life assessment change defined by Sickness Impact Profile total score at 30 days and 6 months between groups. This is a percentage result ranges usually from 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EncephalApp performance change</measure>
    <time_frame>30 days, 60 days and 6 months</time_frame>
    <description>Cognitive assessment change using the OffTime+OnTime in seconds between groups at 30 days, 60 days and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychometric hepatic encephalopathy score (PHES) change</measure>
    <time_frame>30 days, 60 days and 6 months</time_frame>
    <description>Cognitive assessment change using the total PHES score between groups at 30 days, 60 days and 6 months. This ranges from -15 to +5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbial diversity in saliva</measure>
    <time_frame>6 months</time_frame>
    <description>Shannon diversity index compared to baseline at 30 days and then monthly till 6 months. Ranges usually from 0-10</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cirrhosis</condition>
  <condition>Hepatic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral and rectal placebo at visit 2 Oral placebo at day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Oral placebo and rectal FMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral placebo and rectal FMT at visit 2 Oral placebo at day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Oral FMT and rectal placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral FMT and rectal placebo at visit 2 Oral FMT at day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1: Dual Oral and rectal FMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual Oral and rectal FMT at visit 2 Oral FMT at day 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fecal Microbial transplant Capsules</intervention_name>
    <description>Oral capsules of FMT</description>
    <arm_group_label>Group 1: Dual Oral and rectal FMT</arm_group_label>
    <arm_group_label>Group 2: Oral FMT and rectal placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fecal Microbial Transplant Enema</intervention_name>
    <description>FMT enema</description>
    <arm_group_label>Group 1: Dual Oral and rectal FMT</arm_group_label>
    <arm_group_label>Group 3: Oral placebo and rectal FMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Group 3: Oral placebo and rectal FMT</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cirrhosis diagnosed by either of the following in a patient with chronic liver disease&#xD;
&#xD;
               -  Liver Biopsy&#xD;
&#xD;
               -  Radiologic evidence of varices, cirrhosis or portal hypertension&#xD;
&#xD;
               -  Laboratory evidence of platelet count &lt;100,000 or AST/ALT ratio&gt;1&#xD;
&#xD;
               -  Endoscopic evidence of varices or portal gastropathy&#xD;
&#xD;
               -  Fibroscan values suggestive of cirrhosis&#xD;
&#xD;
          -  On treatment for hepatic encephalopathy (patient can be on lactulose and rifaximin)&#xD;
&#xD;
          -  Able to give written, informed consent (demonstrated by mini-mental status exam&gt;25 at&#xD;
             the time of consenting)&#xD;
&#xD;
          -  Women of child bearing potential must agree to use effective contraception for the&#xD;
             duration of the study and for 10 days prior and 30 days after the study&#xD;
&#xD;
          -  Negative pregnancy test in women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MELD score &gt;22&#xD;
&#xD;
          -  WBC count &lt;1000 cells/mm3&#xD;
&#xD;
          -  Platelet count&lt;25,000/mm3&#xD;
&#xD;
          -  TIPS in place for less than a month&#xD;
&#xD;
          -  Currently on antibiotics apart from rifaximin&#xD;
&#xD;
          -  Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis,&#xD;
             paracentesis as needed)&#xD;
&#xD;
          -  Hospitalization for any non-elective cause within the last 1 month&#xD;
&#xD;
          -  Patients who are pregnant or nursing (will be checked using a urine pregnancy test)&#xD;
&#xD;
          -  Patients who are incarcerated&#xD;
&#xD;
          -  Patients who are incapable of giving their own informed consent&#xD;
&#xD;
          -  Patients who are immuno-compromised due to the following reasons:&#xD;
&#xD;
               -  HIV infection (any CD4 count)&#xD;
&#xD;
               -  Inherited/primary immune disorders&#xD;
&#xD;
               -  Current or recent (&lt;3 mos) treatment with anti-neoplastic agent&#xD;
&#xD;
               -  Current or recent (&lt;3 mos) treatment with any immunosuppressant medications&#xD;
                  [including but not limited to monoclonal antibodies to B and T cells, anti-TNF&#xD;
                  agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine),&#xD;
                  calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil].&#xD;
&#xD;
                    -  Subjects who are otherwise immunocompetent and have discontinued any&#xD;
                       immunosuppressant medications 3 or more months prior to enrollment may be&#xD;
                       eligible to enroll&#xD;
&#xD;
          -  Patients on renal replacement therapy&#xD;
&#xD;
          -  Patients with untreated, in-situ colorectal cancer&#xD;
&#xD;
          -  Patients with a history of chronic intrinsic GI diseases such as inflammatory bowel&#xD;
             disease&#xD;
&#xD;
               -  ulcerative colitis, Crohn's disease or microscopic colitis&#xD;
&#xD;
                    -  eosinophilic gastroenteritis or celiac disease&#xD;
&#xD;
          -  Major gastro-intestinal or intra-abdominal surgery in the last three months&#xD;
&#xD;
        Other Exclusion Criteria:&#xD;
&#xD;
          -  Enema-related&#xD;
&#xD;
               -  Platelet count&lt;25,000&#xD;
&#xD;
               -  Grade IV hemorrhoids&#xD;
&#xD;
          -  Safety-related:&#xD;
&#xD;
               -  Dysphagia&#xD;
&#xD;
               -  History of aspiration, gastroparesis, intestinal obstruction&#xD;
&#xD;
               -  Ongoing antibiotic use (except for Rifaximin)&#xD;
&#xD;
               -  Severe anaphylactic food allergy&#xD;
&#xD;
               -  Allergy to ingredients Generally Recognized As Safe in the FMT capsules&#xD;
                  (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma&#xD;
                  oil)&#xD;
&#xD;
               -  Adverse event attributable to prior FMT&#xD;
&#xD;
               -  ASA Class IV or V&#xD;
&#xD;
               -  Pregnant or nursing patients&#xD;
&#xD;
               -  Acute illness or fever within 48 hours of the day of planned FMT&#xD;
&#xD;
               -  Immunocompromised due to medical conditions&#xD;
&#xD;
               -  Probiotics use within the last 48 hours of the day of planned FMT&#xD;
&#xD;
               -  Any condition that the physician investigators deem unsafe, including other&#xD;
                  conditions or medications that the investigator determines puts the participant&#xD;
                  at greater risk from FMT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jasmohan S. Bajaj, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunter Holmes McGuire VA Medical Center, Richmond, VA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jasmohan S Bajaj, MD MS</last_name>
    <phone>(804) 675-5802</phone>
    <email>Jasmohan.Bajaj@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Edith A Gavis, RN</last_name>
    <phone>(804) 675-5584</phone>
    <email>edith.gavis@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hunter Holmes McGuire VA Medical Center, Richmond, VA</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edith A Gavis, RN</last_name>
      <phone>804-675-5584</phone>
      <email>edith.gavis@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Jasmohan S Bajaj, MD MS</last_name>
      <phone>(804) 675-5802</phone>
      <email>Jasmohan.Bajaj@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Jasmohan S. Bajaj, MD MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fecal microbial transplant</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>hepatic encephalopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Hepatic Encephalopathy</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Fibrosis</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/NCT03796598
org study id: GAST-001-18S
secondary id: CX001076
nct id: NCT03796598
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Patients with end stage of liver disease or cirrhosis can develop confusion due to high
      ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the
      bowels and may not respond to current standard of care treatments. Repeated episodes of
      confusion can make it difficult for patients to function and may result in multiple
      admissions to the hospital and burden on the family. The investigators have studied using a
      healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in
      small studies with good results. In this trial the investigators propose to perform these
      procedures using an upper and lower route in Veterans who suffer from this condition and
      follow them for safety and hospitalizations over 6 months. The investigators will compare
      this to placebo treatments and hope that this intervention can improve the health and daily
      functioning of affected patients.
Indication: Cirrhosis and hepatic encephalopathy

      Study Objectives: To evaluate the safety and tolerability of fecal transplant in patients
      with cirrhosis and hepatic encephalopathy

      Rationale and Supporting Evidence:

      Hepatic encephalopathy affects 30-45% of patients with cirrhosis and adversely affects
      survival in these patients. The mainstay of treatment for hepatic encephalopathy (HE) has
      long been the manipulation of the gut flora through antibiotics, prebiotics or probiotics.
      The current first and second line therapies for HE in the US are lactulose and rifaximin
      respectively that uniquely act within the confines of the gut lumen with encouraging clinical
      results. However, there is a subset of patients with HE that continues to recur despite being
      on both treatments. This patient group is at a higher risk of poor outcomes because HE has
      now been removed from liver transplant priority and multiple episodes of HE can result in
      cumulative brain injury which may be irreversible. Therefore, the prevention of recurrent HE
      is an important therapeutic goal.

      The investigators' group and other reports have shown that patients with HE and cirrhosis are
      more likely to have overgrowth of potentially pathogenic bacterial taxa such as
      Enterobacteriaceae and reduction of autochthonous species such as Lachnospiraceae and
      Ruminococcaceae in the stool and the colonic mucosa. This has been linked to poor performance
      on cognitive tests that are a hallmark of HE and with increased systemic inflammation in
      these patients.

      Therefore, a gut-based therapeutic option that can potentially improve the recurrence rate
      and the overall prognosis is needed. Fecal transplant has been shown to be effective in
      conditions with predominant gut-bacterial overgrowth or alteration such as recurrent
      Clostridium difficile and inflammatory bowel disease. Safe protocols have been developed
      across the world and studies are being performed in the US under FDA-monitored INDs.
      Limitations to performing fecal transplant include identifying and screening appropriate
      donors, which is time consuming and costly, with the cost typically falling to the patient or
      donor as the required screening is generally not covered by insurance.

      The investigators' preliminary data suggest that a one-time administration of an FMT-enema
      using a rationally-selected donor is safe in patients with cirrhosis and recurrent HE.
      However, given the small bowel overgrowth and the predominantly small bowel location for
      bacterial translocation in cirrhosis, which is out of the reach of an enema, an upper GI
      route for FMT needs to be explored. In the investigators' published experience, a single
      enema from a rationally-derived donor was associated with significantly lower total and
      HE-related hospitalizations compared to patients who were randomized to standard of care,
      with a stable long-term course over >1 year. The investigators' data show that FMT was
      associated with favorable changes in fecal bile acid (BA) profile with a decrease in
      proportions of fecal secondary BAs, conjugated BAs and increase in sulfated BAs, indicating a
      healthier milieu. The investigators also have preliminary data defining the safety of oral
      FMT capsules in patients with cirrhosis and HE in a current trial led by us. The use of
      combined oral and rectal routes of FMT, which can potentially alleviate both small bowel and
      colonic translocation are likely to be better than either alone.

      Overall aim: To determine the effect of dual oral and rectal administration of FMT from a
      rational donor on clinical outcomes (hospitalizations, brain function, quality of life) and
      host-microbiota interactions (microbial composition and bile acid composition with systemic
      and intestinal inflammation), compared to single route of administration and placebo, along
      with a second oral capsular FMT vs placebo administration in cirrhotic patients with HE using
      a randomized, phase II clinical trial.

      Design overview: Four groups of outpatients with cirrhosis will be randomized using random
      sequence generator into placebo and FMT groups and followed for 6 months under an FDA IND
      double-blind clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be divided into 4 groups via randomization
Group 1: Dual oral and rectal FMT, Group 2: Oral FMT and rectal placebo, Group 3: Oral placebo and rectal FMT and Group 4: Oral and rectal placebo
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Serious adverse events related to FMT
time frame: 6 months
description: Number of serious adverse events between groups related to FMT
measure: Adverse events related to FMT
time frame: 6 months
description: Number of adverse events that do not fit the criteria of serious adverse events between groups related to FMT
measure: Change in microbial diversity in stool
time frame: 6 months
description: Shannon diversity index compared to baseline and engraftment related to the donor at baseline, within 30 days and then monthly till 6 months. Ranges usually from 0-10
measure: Sickness Impact Profile change
time frame: 30 days and 6 months
description: Quality of life assessment change defined by Sickness Impact Profile total score at 30 days and 6 months between groups. This is a percentage result ranges usually from 0-100
measure: EncephalApp performance change
time frame: 30 days, 60 days and 6 months
description: Cognitive assessment change using the OffTime+OnTime in seconds between groups at 30 days, 60 days and 6 months
measure: Psychometric hepatic encephalopathy score (PHES) change
time frame: 30 days, 60 days and 6 months
description: Cognitive assessment change using the total PHES score between groups at 30 days, 60 days and 6 months. This ranges from -15 to +5
measure: Change in microbial diversity in saliva
time frame: 6 months
description: Shannon diversity index compared to baseline at 30 days and then monthly till 6 months. Ranges usually from 0-10
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral and rectal placebo at visit 2 Oral placebo at day 30
arm group label: Group 3: Oral placebo and rectal FMT
arm group type: Active Comparator
description: Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
arm group label: Group 2: Oral FMT and rectal placebo
arm group type: Active Comparator
description: Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
arm group label: Group 1: Dual Oral and rectal FMT
arm group type: Experimental
description: Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
intervention type: Drug
intervention name: Fecal Microbial transplant Capsules
description: Oral capsules of FMT
arm group label: Group 1: Dual Oral and rectal FMT
arm group label: Group 2: Oral FMT and rectal placebo
intervention type: Drug
intervention name: Fecal Microbial Transplant Enema
description: FMT enema
arm group label: Group 1: Dual Oral and rectal FMT
arm group label: Group 3: Oral placebo and rectal FMT
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Group 3: Oral placebo and rectal FMT
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jasmohan S. Bajaj, MD MS
role: Principal Investigator
affiliation: Hunter Holmes McGuire VA Medical Center, Richmond, VA
last name: Jasmohan S Bajaj, MD MS
phone: (804) 675-5802
email: Jasmohan.Bajaj@va.gov
last name: Edith A Gavis, RN
phone: (804) 675-5584
email: edith.gavis@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Hepatic Encephalopathy
mesh term: Brain Diseases
mesh term: Fibrosis
sharing ipd: No