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

Acute on Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689245
• Other study ID #: ILBS-ACLF-007
• Status: Completed
• Phase: N/A
• Start date: February 26, 2016
• Est. completion date: March 13, 2018

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatitis B
• Liver Failure

Intervention

Drug:
• Tenofovir

• Fecal Microbiota Transplantation (FMT)

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival.		3 months
Secondary	Reduction in Hepatitis B Virus DNA level = 2 log.		2 weeks
Secondary	Improvement in MELD (Model for End Stage Liver Disease) score.		2 weeks
Secondary	Improvement in CTP (Child Pugh Turcotte) score.		2 weeks
Secondary	Mortality		1 Month
Secondary	Mortality		3 Months
Secondary	Improvement in hepatic Encephalopathy.	Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.	7 days
Secondary	Improvement in International Normalized ratio.	Improvement is defined as International Normalized ratio value within normal limits	7 days
Secondary	Improvement in Total bilirubin.	Improvement is defined as Total bilirubin value within normal limits.	7 days
Secondary	Development of infectious complications during follow up in both groups		7,15,30 and 90 days
Secondary	Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups		7,15,30 and 90 days
Secondary	Improvement in SOFA (Sequential organ failure assessment) score in both groups.		7,15,30 and 90 days
Secondary	Change in gut microbiome in both the groups		0,7,15,30 and 90 days
Secondary	Assessment of organ failures in both groups		7,15,30 and 90 days