Clinical Trial: Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
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.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Transplant free survival. [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. [ Time Frame: 7 days ]Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
- Improvement in International Normalized ratio. [ Time Frame: 7 days ]Improvement is defined as International Normalized ratio value within normal limits
- Improvement in Total bilirubin. [ Time Frame: 7 days ]Improvement is defined as Total bilirubin value within normal limits.
- 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 [ 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 ]
Original Secondary Outcome:
- 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. [ Time Frame: 7 days ]Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
- Improvement in International Normalized ratio. [ Time Frame: 7 days ]Improvement is defined as International Normalized ratio value within normal limits
- Improvement in Total bilirubin. [ Time Frame: 7 days ]Improvement is defined as Total bilirubin value within normal limits.
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: February 13, 2016
Date Started: February 2016
Date Completion: February 2017
Last Updated: October 5, 2016
Last Verified: September 2016