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

Not Applicable

Completed

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Tenofovir; Drug: Fecal Microbiota Transplantation (FMT)

• Registration Number: NCT02689245
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-13
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Study Start: 2016-02-26
• Status Verified: 2018-02
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir + Fecal Microbiota Transplantation (FMT)	Fecal Microbiota Transplantation (FMT)	-
Tenofovir + Fecal Microbiota Transplantation (FMT)	Tenofovir	-
Tenofovir	Tenofovir	-

Primary Outcome Measures

Name	Time	Method
Transplant free survival.	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India