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Completed

NCT Number: NCT02689245

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

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.

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Key information

Conditions

Acute on Chronic Liver Failure Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
  • 18-75 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.

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

Treatment and study plan

Tenofovir

Drug

Fecal microbiota transplantation (FMT)

Drug

Primary outcomes

  1. Transplant free survival.

    Time frame: 3 months

Secondary outcomes

  1. Reduction in Hepatitis B Virus DNA level ≥ 2 log.

    Time frame: 2 weeks

  2. Improvement in MELD (Model for End Stage Liver Disease) score.

    Time frame: 2 weeks

  3. Improvement in CTP (Child Pugh Turcotte) score.

    Time frame: 2 weeks

  4. Mortality

    Time frame: 1 Month

  5. Mortality

    Time frame: 3 Months

  6. Improvement in hepatic Encephalopathy.

    Time frame: 7 days

    Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.

  7. Improvement in International Normalized ratio.

    Time frame: 7 days

    Improvement is defined as International Normalized ratio value within normal limits

  8. Improvement in Total bilirubin.

    Time frame: 7 days

    Improvement is defined as Total bilirubin value within normal limits.

  9. Development of infectious complications during follow up in both groups

    Time frame: 7,15,30 and 90 days

  10. Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups

    Time frame: 7,15,30 and 90 days

  11. Improvement in SOFA (Sequential organ failure assessment) score in both groups.

    Time frame: 7,15,30 and 90 days

  12. Change in gut microbiome in both the groups

    Time frame: 0,7,15,30 and 90 days

  13. Assessment of organ failures in both groups

    Time frame: 7,15,30 and 90 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2016
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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