Acute on Chronic Liver Failure
Conditions
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.
Interventions
DRUGTenofovir
DRUGFecal Microbiota Transplantation (FMT)
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant free survival. | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in MELD (Model for End Stage Liver Disease) score. | 2 weeks | — |
| Improvement in CTP (Child Pugh Turcotte) score. | 2 weeks | — |
| Mortality | 1 Month | — |
| Improvement in hepatic Encephalopathy. | 7 days | Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value. |
| Improvement in International Normalized ratio. | 7 days | Improvement is defined as International Normalized ratio value within normal limits |
| Reduction in Hepatitis B Virus DNA level ≥ 2 log. | 2 weeks | — |
| 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 | — |
| Improvement in Total bilirubin. | 7 days | Improvement is defined as Total bilirubin value within normal limits. |
Countries
India
Outcome results
None listed