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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02689245
Other study ID # ILBS-ACLF-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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