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

Primary Purpose

Acute on Chronic Liver Failure

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Tenofovir

Fecal Microbiota Transplantation (FMT)

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
18-75 yr both male and female
Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
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

Sites / Locations

Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tenofovir + Fecal Microbiota Transplantation (FMT)

Tenofovir

Arm Description

Outcomes

Primary Outcome Measures

Transplant free survival.

Secondary Outcome Measures

Reduction in Hepatitis B Virus DNA level ≥ 2 log.

Improvement in MELD (Model for End Stage Liver Disease) score.

Improvement in CTP (Child Pugh Turcotte) score.

Mortality

Improvement in hepatic Encephalopathy.

Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.

Improvement in International Normalized ratio.

Improvement is defined as International Normalized ratio value within normal limits

Improvement in Total bilirubin.

Improvement is defined as Total bilirubin value within normal limits.

Development of infectious complications during follow up in both groups

Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups

Improvement in SOFA (Sequential organ failure assessment) score in both groups.

Change in gut microbiome in both the groups

Assessment of organ failures in both groups

Full Information

NCT ID

NCT02689245

First Posted

February 13, 2016

Last Updated

November 21, 2018

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02689245

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

February 26, 2016 (Actual)

Primary Completion Date

March 13, 2018 (Actual)

Study Completion Date

March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute on Chronic Liver Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tenofovir + Fecal Microbiota Transplantation (FMT)

Arm Type

Experimental

Arm Title

Tenofovir

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tenofovir

Intervention Type

Drug

Intervention Name(s)

Fecal Microbiota Transplantation (FMT)

Primary Outcome Measure Information:

Title

Transplant free survival.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Reduction in Hepatitis B Virus DNA level ≥ 2 log.

Time Frame

2 weeks

Title

Improvement in MELD (Model for End Stage Liver Disease) score.

Time Frame

2 weeks

Title

Improvement in CTP (Child Pugh Turcotte) score.

Time Frame

2 weeks

Title

Mortality

Time Frame

1 Month

Title

Mortality

Time Frame

3 Months

Title

Improvement in hepatic Encephalopathy.

Description

Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.

Time Frame

7 days

Title

Improvement in International Normalized ratio.

Description

Improvement is defined as International Normalized ratio value within normal limits

Time Frame

7 days

Title

Improvement in Total bilirubin.

Description

Improvement is defined as Total bilirubin value within normal limits.

Time Frame

7 days

Title

Development of infectious complications during follow up in both groups

Time Frame

7,15,30 and 90 days

Title

Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups

Time Frame

7,15,30 and 90 days

Title

Improvement in SOFA (Sequential organ failure assessment) score in both groups.

Time Frame

7,15,30 and 90 days

Title

Change in gut microbiome in both the groups

Time Frame

0,7,15,30 and 90 days

Title

Assessment of organ failures in both groups

Time Frame

7,15,30 and 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years. 18-75 yr both male and female Chronic Hepatitis B patient (precirrhotic,compensated,decompensated). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Juned Ahmad, MD

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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