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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Acute on Chronic Liver Failure

Intervention / Treatment
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* Drug: Tenofovir
* Drug: Fecal Microbiota Transplantation (FMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir + Fecal Microbiota Transplantation (FMT)<br> | Drug: Tenofovir<br> <br> Drug: Fecal Microbiota Transplantation (FMT)<br> <br> |
| Active Comparator: Tenofovir<br> | Drug: Tenofovir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |