<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/NCT04431375</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-ACLF-05</org_study_id>
    <nct_id>NCT04431375</nct_id>
  </id_info>
  <brief_title>Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV</brief_title>
  <official_title>Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      A randomized controlled trial to study the efficacy of addition of FMT &amp; plasma exchange to&#xD;
      tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who&#xD;
      develops Acute on chronic liver failure.&#xD;
&#xD;
      In this study the patients who meet the inclusion criteria will be randomized to either&#xD;
      receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples &amp; stool&#xD;
      samples will be taken &amp; analysis will be done accordingly .The patients are followed for 90&#xD;
      days MELD,APACHE &amp; SOFA scores are calculated.Then statistical analysis will be done to find&#xD;
      whether the addition of plasma exchange &amp; FMT adds benefit compared to tenofovir treatment&#xD;
      alone .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial to study the efficacy of addition of FMT &amp; plasma exchange to&#xD;
      tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who&#xD;
      develops Acute on chronic liver failure.&#xD;
&#xD;
      In this study the patients who meet the inclusion criteria will be randomized to either&#xD;
      receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples &amp; stool&#xD;
      samples will be taken &amp; analysis will be done accordingly .The patients are followed for 90&#xD;
      days MELD,APACHE &amp; SOFA scores are calculated.Then statistical analysis will be done to find&#xD;
      whether the addition of plasma exchange &amp; FMT adds benefit compared to tenofovir treatment&#xD;
      alone .&#xD;
&#xD;
      Study period: 2 Years&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The patients in Group A will receive T.Tenofovir [antiviral] 300mg per oral once a day .&#xD;
&#xD;
      The patients in Group B will receive Plasma exchange 2 sessions alternate day followed by FMT&#xD;
      for 7 days and Tenofovir [antiviral] 300mg PO once a day .&#xD;
&#xD;
      Intravenous antibiotics will be given to all patients included in study empirically, because&#xD;
      of high risk of infection in these patients. Patients with sepsis are excluded from the&#xD;
      study.&#xD;
&#xD;
      Methodology for FMT - Fresh Stool [30 g] is obtained from donor &lt;3 hr before FMT. 150 mL&#xD;
      sterile 0.9N saline is added to sample &amp; homogenized in a blender. It is Continued 3 times in&#xD;
      pulses of 20-30 secs, till homogenous suspension. Slow filtration is done with membrane&#xD;
      filter (330µm) to give adequate time. Filtration is repeated 3 times. Patient is kept NPO for&#xD;
      4 hrs. prior to the instillation .100 ml of fresh filtrate is given for 7 days through&#xD;
      naso-jejunal tube over 5-10 minutes .Patient is kept reclined at 45° for 4 hr. Normal diet is&#xD;
      given after 2 hr of procedure. IV antibiotics are continued as per institutional protocol in&#xD;
      case of sepsis.&#xD;
&#xD;
      Methodology for plasma exchange [PE] - Circulatory access will be established through a&#xD;
      double lumen catheter via the patient's femoral vein. The total exchanged plasma volume will&#xD;
      be 2500-3500 mL, and the Plasma Exchange rate will be 20-25 mL/min. Fresh-frozen plasma (FFP)&#xD;
      will be supplied by the ILBS Blood Bank. Dexamethasone (5 mg) and heparin (2500 U) will be&#xD;
      injected routinely before PE. Heparin will be neutralized at the end of PE by an injection of&#xD;
      20-50 mg protamine sulfate. PE will be repeated alternate day for a total of 2 sessions&#xD;
      Adverse effects: FMT FMT - Sore throat and difficulty in deglutition secondary to&#xD;
      naso-gastric tube insertion Plasma exchange PE&#xD;
&#xD;
        -  Hypocalcemia&#xD;
&#xD;
        -  Hypokalemia&#xD;
&#xD;
        -  Metabolic alkalosis&#xD;
&#xD;
        -  Hypotension&#xD;
&#xD;
        -  Anaphylaxis&#xD;
&#xD;
        -  TRALI TENOFOVIR Tenofovir&#xD;
&#xD;
        -  Reversible proximal renal tubular toxicity.&#xD;
&#xD;
        -  Reduced bone mineral density&#xD;
&#xD;
        -  Manifestations of mitochondrial toxicity (i.e., neuropathy, myopathy, lactic acidosis&#xD;
&#xD;
      Stopping rule of study:&#xD;
&#xD;
        -  Allergic reactions except mild drug reactions&#xD;
&#xD;
        -  Arterial hypotension or development of shock /Hypertension&#xD;
&#xD;
        -  Arrhythmias&#xD;
&#xD;
        -  Development or progression of organ failures during therapy&#xD;
&#xD;
        -  Transfusion related lung injury&#xD;
&#xD;
        -  Uncontrolled Bleeding or DIC&#xD;
&#xD;
        -  Severe dyselectrolytemia( k+&lt;2.5 or &gt;5.5)&#xD;
&#xD;
        -  Seizures/tetany&#xD;
&#xD;
        -  Patients who are undergoing or listed for Transplantation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2022</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival in both groups</measure>
    <time_frame>Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival in both groups</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in HBV DNA level</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in HBV DNA level</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in HBV DNA level</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in CTP Score in both groups</measure>
    <time_frame>14 days</time_frame>
    <description>CTP Score ranges from 5 to 15 5=good 15=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in CTP Score in both groups</measure>
    <time_frame>30 days</time_frame>
    <description>CTP Score ranges from 5 to 15 5=good 15=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in CTP Score in both groups</measure>
    <time_frame>60 days</time_frame>
    <description>CTP Score ranges from 5 to 15 5=good 15=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in CTP Score in both groups</measure>
    <time_frame>90 days</time_frame>
    <description>CTP Score ranges from 5 to 15 5=good 15=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in MELD Score in both groups</measure>
    <time_frame>14 days</time_frame>
    <description>MELD Score ranges from 6 to 40 6=good 40=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in MELD Score in both groups</measure>
    <time_frame>30 days</time_frame>
    <description>MELD Score ranges from 6 to 40 6=good 40=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in MELD Score in both groups</measure>
    <time_frame>60 days</time_frame>
    <description>MELD Score ranges from 6 to 40 6=good 40=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in MELD Score in both groups</measure>
    <time_frame>90 days</time_frame>
    <description>MELD Score ranges from 6 to 40 6=good 40=worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by MELD Na and CTP scores.</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by MELD Na</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by CTP scores.</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by MELD Na</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by CTP scores.</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by MELD Na.</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient's with improvement in hepatic failure calculated by CTP scores.</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiota profile in both groups</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiota profile in both groups</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiota profile in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiota profile in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cytokine profile in both groups</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cytokine profile in both groups</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma cytokine profile in both groups</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse Events in both groups</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Acute-On-Chronic Liver Failure</condition>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>plasma Exchange+Tenofovir+FMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TabletTenofovir [antiviral] 300mg per oral once a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Plasma Exchange</intervention_name>
    <description>Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .</description>
    <arm_group_label>plasma Exchange+Tenofovir+FMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir</intervention_name>
    <description>Tenofovir [antiviral] 300mg PO once a day .</description>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_label>plasma Exchange+Tenofovir+FMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fecal Mircobiota Transplantation</intervention_name>
    <description>FMT for 7 days</description>
    <arm_group_label>plasma Exchange+Tenofovir+FMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age - 18-75 years&#xD;
&#xD;
          -  Patients with ACLF - HBV reactivation according to APASL guidelines.&#xD;
&#xD;
          -  MELD &lt; 30 WITH AKI,HE&#xD;
&#xD;
          -  MELD &lt; 30 WITH OUT EXTRAHEPATIC FAILURE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MELD &gt; 30&#xD;
&#xD;
          -  Co existing hepatitis A,E,D&#xD;
&#xD;
          -  HCC&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea&#xD;
&#xD;
          -  Allergy to plasma, protamine or heparin,&#xD;
&#xD;
          -  Active hemorrhage or disseminated intravascular coagulation (DIC)&#xD;
&#xD;
          -  Unstable hemodynamics (e.g., blood pressure &lt;90/60 mmHg, heart rate &gt;100 bpm),&#xD;
&#xD;
          -  Cerebral or myocardiac infarction&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr G. Srinivasa Reddy, MD</last_name>
    <phone>01146300000</phone>
    <email>srinivasareddygolamari@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr G Srinivasa Reddy, MD</last_name>
      <phone>01146300000</phone>
      <email>srinivasareddygolamari@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 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>Hepatitis B</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>End Stage Liver Disease</mesh_term>
    <mesh_term>Acute-On-Chronic Liver Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04431375
org study id: ILBS-ACLF-05
nct id: NCT04431375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to
      tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who
      develops Acute on chronic liver failure.

      In this study the patients who meet the inclusion criteria will be randomized to either
      receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool
      samples will be taken & analysis will be done accordingly .The patients are followed for 90
      days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find
      whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment
      alone .
A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to
      tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who
      develops Acute on chronic liver failure.

      In this study the patients who meet the inclusion criteria will be randomized to either
      receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool
      samples will be taken & analysis will be done accordingly .The patients are followed for 90
      days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find
      whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment
      alone .

      Study period: 2 Years

      Intervention:

      The patients in Group A will receive T.Tenofovir [antiviral] 300mg per oral once a day .

      The patients in Group B will receive Plasma exchange 2 sessions alternate day followed by FMT
      for 7 days and Tenofovir [antiviral] 300mg PO once a day .

      Intravenous antibiotics will be given to all patients included in study empirically, because
      of high risk of infection in these patients. Patients with sepsis are excluded from the
      study.

      Methodology for FMT - Fresh Stool [30 g] is obtained from donor <3 hr before FMT. 150 mL
      sterile 0.9N saline is added to sample & homogenized in a blender. It is Continued 3 times in
      pulses of 20-30 secs, till homogenous suspension. Slow filtration is done with membrane
      filter (330µm) to give adequate time. Filtration is repeated 3 times. Patient is kept NPO for
      4 hrs. prior to the instillation .100 ml of fresh filtrate is given for 7 days through
      naso-jejunal tube over 5-10 minutes .Patient is kept reclined at 45° for 4 hr. Normal diet is
      given after 2 hr of procedure. IV antibiotics are continued as per institutional protocol in
      case of sepsis.

      Methodology for plasma exchange [PE] - Circulatory access will be established through a
      double lumen catheter via the patient's femoral vein. The total exchanged plasma volume will
      be 2500-3500 mL, and the Plasma Exchange rate will be 20-25 mL/min. Fresh-frozen plasma (FFP)
      will be supplied by the ILBS Blood Bank. Dexamethasone (5 mg) and heparin (2500 U) will be
      injected routinely before PE. Heparin will be neutralized at the end of PE by an injection of
      20-50 mg protamine sulfate. PE will be repeated alternate day for a total of 2 sessions
      Adverse effects: FMT FMT - Sore throat and difficulty in deglutition secondary to
      naso-gastric tube insertion Plasma exchange PE

        -  Hypocalcemia

        -  Hypokalemia

        -  Metabolic alkalosis

        -  Hypotension

        -  Anaphylaxis

        -  TRALI TENOFOVIR Tenofovir

        -  Reversible proximal renal tubular toxicity.

        -  Reduced bone mineral density

        -  Manifestations of mitochondrial toxicity (i.e., neuropathy, myopathy, lactic acidosis

      Stopping rule of study:

        -  Allergic reactions except mild drug reactions

        -  Arterial hypotension or development of shock /Hypertension

        -  Arrhythmias

        -  Development or progression of organ failures during therapy

        -  Transfusion related lung injury

        -  Uncontrolled Bleeding or DIC

        -  Severe dyselectrolytemia( k+<2.5 or >5.5)

        -  Seizures/tetany

        -  Patients who are undergoing or listed for Transplantation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival in both groups
time frame: Day 28
measure: Overall survival in both groups
time frame: 3 months
measure: Reduction in HBV DNA level
time frame: 14 days
measure: Reduction in HBV DNA level
time frame: 60 days
measure: Reduction in HBV DNA level
time frame: 90 days
measure: Reduction in CTP Score in both groups
time frame: 14 days
description: CTP Score ranges from 5 to 15 5=good 15=worst
measure: Reduction in CTP Score in both groups
time frame: 30 days
description: CTP Score ranges from 5 to 15 5=good 15=worst
measure: Reduction in CTP Score in both groups
time frame: 60 days
description: CTP Score ranges from 5 to 15 5=good 15=worst
measure: Reduction in CTP Score in both groups
time frame: 90 days
description: CTP Score ranges from 5 to 15 5=good 15=worst
measure: Reduction in MELD Score in both groups
time frame: 14 days
description: MELD Score ranges from 6 to 40 6=good 40=worst
measure: Reduction in MELD Score in both groups
time frame: 30 days
description: MELD Score ranges from 6 to 40 6=good 40=worst
measure: Reduction in MELD Score in both groups
time frame: 60 days
description: MELD Score ranges from 6 to 40 6=good 40=worst
measure: Reduction in MELD Score in both groups
time frame: 90 days
description: MELD Score ranges from 6 to 40 6=good 40=worst
measure: Percentage of patient's with improvement in hepatic failure calculated by MELD Na and CTP scores.
time frame: 14 days
measure: Percentage of patient's with improvement in hepatic failure calculated by MELD Na
time frame: 30 days
measure: Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
time frame: 30 days
measure: Percentage of patient's with improvement in hepatic failure calculated by MELD Na
time frame: 60 days
measure: Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
time frame: 60 days
measure: Percentage of patient's with improvement in hepatic failure calculated by MELD Na.
time frame: 90 days
measure: Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
time frame: 90 days
measure: Change in microbiota profile in both groups
time frame: 10 days
measure: Change in microbiota profile in both groups
time frame: 30 days
measure: Change in microbiota profile in both groups
time frame: 60 days
measure: Change in microbiota profile in both groups
time frame: 90 days
measure: Change in plasma cytokine profile in both groups
time frame: 10 days
measure: Change in plasma cytokine profile in both groups
time frame: 28 days
measure: Change in plasma cytokine profile in both groups
time frame: 60 days
measure: Number of patients with adverse Events in both groups
time frame: 90 days
arm group label: plasma Exchange+Tenofovir+FMT
arm group type: Experimental
description: Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
arm group label: Tenofovir
arm group type: Active Comparator
description: TabletTenofovir [antiviral] 300mg per oral once a day
intervention type: Biological
intervention name: Plasma Exchange
description: Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
arm group label: plasma Exchange+Tenofovir+FMT
intervention type: Drug
intervention name: Tenofovir
description: Tenofovir [antiviral] 300mg PO once a day .
arm group label: Tenofovir
arm group label: plasma Exchange+Tenofovir+FMT
intervention type: Other
intervention name: Fecal Mircobiota Transplantation
description: FMT for 7 days
arm group label: plasma Exchange+Tenofovir+FMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr G. Srinivasa Reddy, MD
phone: 01146300000
email: srinivasareddygolamari@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Liver Failure
mesh term: End Stage Liver Disease
mesh term: Acute-On-Chronic Liver Failure
mesh term: Tenofovir
sharing ipd: Undecided