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