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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir + Fecal Microbiota Transplantation (FMT) | Experimental |
| |
| Tenofovir | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug |
| ||
| Fecal Microbiota Transplantation (FMT) |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival. | 3 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Juned Ahmad, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Drug |
|
| 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 |
| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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