Clinical trial NCT02689245: Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
Official title: Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Transplant free survival.
timeFrame: 3 months
Secondary outcomes:
measure: Reduction in Hepatitis B Virus DNA level ≥ 2 log.
timeFrame: 2 weeks
measure: Improvement in MELD (Model for End Stage Liver Disease) score.
timeFrame: 2 weeks
measure: Improvement in CTP (Child Pugh Turcotte) score.
timeFrame: 2 weeks
measure: Mortality
timeFrame: 1 Month
measure: Mortality
timeFrame: 3 Months
measure: Improvement in hepatic Encephalopathy.
timeFrame: 7 days
measure: Improvement in International Normalized ratio.
timeFrame: 7 days
measure: Improvement in Total bilirubin.
timeFrame: 7 days
measure: Development of infectious complications during follow up in both groups
timeFrame: 7,15,30 and 90 days
measure: Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
timeFrame: 7,15,30 and 90 days
measure: Improvement in SOFA (Sequential organ failure assessment) score in both groups.
timeFrame: 7,15,30 and 90 days
measure: Change in gut microbiome in both the groups
timeFrame: 0,7,15,30 and 90 days
measure: Assessment of organ failures in both groups
timeFrame: 7,15,30 and 90 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Juned Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References: