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

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: Acute on Chronic Liver Failure
• Intervention / Treatment: Drug: Tenofovir; Drug: Fecal Microbiota Transplantation (FMT)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Juned Ahmad, MD, Institute of Liver and Biliary Sciences

Study record dates

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: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Liver Failure, Acute; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Hepatitis B; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: ILBS-ACLF-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED