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

NCT04431375 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-01-31

No results posted yet for this study

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 .

Conditions

Interventions

BIOLOGICAL

Plasma Exchange

Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir \[antiviral\] 300mg PO once a day .

DRUG

Tenofovir

Tenofovir \[antiviral\] 300mg PO once a day .

OTHER

Fecal Mircobiota Transplantation

FMT for 7 days

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2022-06-10
Completion
2022-06-10

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04431375 on ClinicalTrials.gov