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

I

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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