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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Transplant free survival.
Time frame: 3 months
Reduction in Hepatitis B Virus DNA level ≥ 2 log.
Time frame: 2 weeks
Improvement in MELD (Model for End Stage Liver Disease) score.
Time frame: 2 weeks
Improvement in CTP (Child Pugh Turcotte) score.
Time frame: 2 weeks
Mortality
Time frame: 1 Month
Mortality
Time frame: 3 Months
Improvement in hepatic Encephalopathy.
Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
Time frame: 7 days
Improvement in International Normalized ratio.
Improvement is defined as International Normalized ratio value within normal limits
Time frame: 7 days
Improvement in Total bilirubin.
Improvement is defined as Total bilirubin value within normal limits.
Time frame: 7 days
Development of infectious complications during follow up in both groups
Time frame: 7,15,30 and 90 days
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
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Time frame: 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
Change in gut microbiome in both the groups
Time frame: 0,7,15,30 and 90 days
Assessment of organ failures in both groups
Time frame: 7,15,30 and 90 days