Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

• Status: Completed
• Trial end date: 2018-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Tenofovir

Criteria

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