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

NCT02689245 | Completed

• 1 other identifier: ILBS-ACLF-007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Transplant free survival.

  3 months

Secondary Outcomes (13)

• 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 CTP (Child Pugh Turcotte) score.

  2 weeks

• Mortality

  1 Month

• Mortality

  3 Months

Study Arms (2)

Tenofovir + Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

Drug: Tenofovir; Drug: Fecal Microbiota Transplantation (FMT)

Tenofovir

ACTIVE COMPARATOR

Drug: Tenofovir

Interventions

Tenofovir DRUG

Tenofovir; Tenofovir + Fecal Microbiota Transplantation (FMT)

Fecal Microbiota Transplantation (FMT) DRUG

Tenofovir + Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) \>18 years.
• yr both male and female
• Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
• Healthy adult family member of the patient will be taken as a control.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Tenofovir; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biological Therapy; Therapeutics

Study Officials

• Dr Juned Ahmad, MD

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: February 23, 2016
• Study Start: February 26, 2016
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-02

Locations

IN (1)