Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV

January 27, 2022 updated by: Institute of Liver and Biliary Sciences, India

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Recruiting
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age - 18-75 years
  • Patients with ACLF - HBV reactivation according to APASL guidelines.
  • MELD < 30 WITH AKI,HE
  • MELD < 30 WITH OUT EXTRAHEPATIC FAILURE

Exclusion Criteria:

  • MELD > 30
  • Co existing hepatitis A,E,D
  • HCC
  • Sepsis
  • Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea
  • Allergy to plasma, protamine or heparin,
  • Active hemorrhage or disseminated intravascular coagulation (DIC)
  • Unstable hemodynamics (e.g., blood pressure <90/60 mmHg, heart rate >100 bpm),
  • Cerebral or myocardiac infarction
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: plasma Exchange+Tenofovir+FMT
Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
Biological: Plasma Exchange
Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
Drug: Tenofovir
Tenofovir [antiviral] 300mg PO once a day .
Other: Fecal Mircobiota Transplantation
FMT for 7 days
ACTIVE_COMPARATOR: Tenofovir
TabletTenofovir [antiviral] 300mg per oral once a day
Drug: Tenofovir
Tenofovir [antiviral] 300mg PO once a day .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival in both groups
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival in both groups
Time Frame: 3 months
3 months
Reduction in HBV DNA level
Time Frame: 14 days
14 days
Reduction in HBV DNA level
Time Frame: 60 days
60 days
Reduction in HBV DNA level
Time Frame: 90 days
90 days
Reduction in CTP Score in both groups
Time Frame: 14 days
CTP Score ranges from 5 to 15 5=good 15=worst
14 days
Reduction in CTP Score in both groups
Time Frame: 30 days
CTP Score ranges from 5 to 15 5=good 15=worst
30 days
Reduction in CTP Score in both groups
Time Frame: 60 days
CTP Score ranges from 5 to 15 5=good 15=worst
60 days
Reduction in CTP Score in both groups
Time Frame: 90 days
CTP Score ranges from 5 to 15 5=good 15=worst
90 days
Reduction in MELD Score in both groups
Time Frame: 14 days
MELD Score ranges from 6 to 40 6=good 40=worst
14 days
Reduction in MELD Score in both groups
Time Frame: 30 days
MELD Score ranges from 6 to 40 6=good 40=worst
30 days
Reduction in MELD Score in both groups
Time Frame: 60 days
MELD Score ranges from 6 to 40 6=good 40=worst
60 days
Reduction in MELD Score in both groups
Time Frame: 90 days
MELD Score ranges from 6 to 40 6=good 40=worst
90 days
Percentage of patient's with improvement in hepatic failure calculated by MELD Na and CTP scores.
Time Frame: 14 days
14 days
Percentage of patient's with improvement in hepatic failure calculated by MELD Na
Time Frame: 30 days
30 days
Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
Time Frame: 30 days
30 days
Percentage of patient's with improvement in hepatic failure calculated by MELD Na
Time Frame: 60 days
60 days
Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
Time Frame: 60 days
60 days
Percentage of patient's with improvement in hepatic failure calculated by MELD Na.
Time Frame: 90 days
90 days
Percentage of patient's with improvement in hepatic failure calculated by CTP scores.
Time Frame: 90 days
90 days
Change in microbiota profile in both groups
Time Frame: 10 days
10 days
Change in microbiota profile in both groups
Time Frame: 30 days
30 days
Change in microbiota profile in both groups
Time Frame: 60 days
60 days
Change in microbiota profile in both groups
Time Frame: 90 days
90 days
Change in plasma cytokine profile in both groups
Time Frame: 10 days
10 days
Change in plasma cytokine profile in both groups
Time Frame: 28 days
28 days
Change in plasma cytokine profile in both groups
Time Frame: 60 days
60 days
Number of patients with adverse Events in both groups
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-ACLF-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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