Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
NCT ID: NCT02689245
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2016-02-26
2018-03-13
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tenofovir + Fecal Microbiota Transplantation (FMT)
Tenofovir
Fecal Microbiota Transplantation (FMT)
Tenofovir
Tenofovir
Interventions
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Tenofovir
Fecal Microbiota Transplantation (FMT)
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Dr Juned Ahmad, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
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Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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ILBS-ACLF-007
Identifier Type: -
Identifier Source: org_study_id
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