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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute on Chronic Liver Failure

Treatments: Drug: Fecal Microbiota Transplantation (FMT); Drug: Tenofovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02689245

ILBS-ACLF-007

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Tenofovir + Fecal Microbiota Transplantation (FMT)

Experimental group

Treatment:

Drug: Tenofovir

Drug: Fecal Microbiota Transplantation (FMT)

Tenofovir

Active Comparator group

Treatment:

Drug: Tenofovir