Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

November 21, 2018 updated by: Institute of Liver and Biliary Sciences, India

Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.

Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).

Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • 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
        • Institute of liver and 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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
  2. 18-75 yr both male and female
  3. Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
  4. Healthy adult family member of the patient will be taken as a control.

Exclusion Criteria:

  • Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
  • Active gastrointestinal bleeding
  • Intracranial bleeding
  • Multi-organ failure (>2) on mechanical ventilation
  • SOFA score >2
  • On high inotropic support
  • Paralytic ileus
  • Pregnancy
  • Hepatocellular Carcinoma
  • Antibiotic,probiotic within last 3 months

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tenofovir
Drug: Tenofovir
Experimental: Tenofovir + Fecal Microbiota Transplantation (FMT)
Drug: Tenofovir
Drug: Fecal Microbiota Transplantation (FMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transplant free survival.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Hepatitis B Virus DNA level ≥ 2 log.
Time Frame: 2 weeks
2 weeks
Improvement in MELD (Model for End Stage Liver Disease) score.
Time Frame: 2 weeks
2 weeks
Improvement in CTP (Child Pugh Turcotte) score.
Time Frame: 2 weeks
2 weeks
Mortality
Time Frame: 1 Month
1 Month
Mortality
Time Frame: 3 Months
3 Months
Improvement in hepatic Encephalopathy.
Time Frame: 7 days
Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
7 days
Improvement in International Normalized ratio.
Time Frame: 7 days
Improvement is defined as International Normalized ratio value within normal limits
7 days
Improvement in Total bilirubin.
Time Frame: 7 days
Improvement is defined as Total bilirubin value within normal limits.
7 days
Development of infectious complications during follow up in both groups
Time Frame: 7,15,30 and 90 days
7,15,30 and 90 days
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
Time Frame: 7,15,30 and 90 days
7,15,30 and 90 days
Improvement in SOFA (Sequential organ failure assessment) score in both groups.
Time Frame: 7,15,30 and 90 days
7,15,30 and 90 days
Change in gut microbiome in both the groups
Time Frame: 0,7,15,30 and 90 days
0,7,15,30 and 90 days
Assessment of organ failures in both groups
Time Frame: 7,15,30 and 90 days
7,15,30 and 90 days

Collaborators and Investigators

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

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Juned Ahmad, MD, Institute of liver and Biliary Sciences

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)

February 26, 2016

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 13, 2018

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-ACLF-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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