Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV

• Status: Recruiting
• Trial end date: 2022-06-10
• Target enrollment: 0
• Participant gender: All

Summary

A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure.

In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .

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

Details

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

Criteria

Inclusion Criteria:

• Age - 18-75 years

• Patients with ACLF - HBV reactivation according to APASL guidelines.

• MELD < 30 WITH AKI,HE

• MELD < 30 WITH OUT EXTRAHEPATIC FAILURE

Exclusion Criteria:

• MELD > 30

• Co existing hepatitis A,E,D

• HCC

• Sepsis

• Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea

• Allergy to plasma, protamine or heparin,

• Active hemorrhage or disseminated intravascular coagulation (DIC)

• Unstable hemodynamics (e.g., blood pressure <90/60 mmHg, heart rate >100 bpm),

• Cerebral or myocardiac infarction

• Pregnancy