Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall survival in both groups
研究概览
简要总结
A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure.
In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .
详细描述
A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure.
In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .
Study period: 2 Years
Intervention:
The patients in Group A will receive T.Tenofovir [antiviral] 300mg per oral once a day .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - 18-75 years
- •Patients with ACLF - HBV reactivation according to APASL guidelines.
- •MELD < 30 WITH AKI,HE
- •MELD < 30 WITH OUT EXTRAHEPATIC FAILURE
排除标准
- •MELD > 30
- •Co existing hepatitis A,E,D
- •Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea
- •Allergy to plasma, protamine or heparin,
- •Active hemorrhage or disseminated intravascular coagulation (DIC)
- •Unstable hemodynamics (e.g., blood pressure <90/60 mmHg, heart rate >100 bpm),
- •Cerebral or myocardiac infarction
- •Pregnancy
研究组 & 干预措施
plasma Exchange+Tenofovir+FMT
Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
干预措施: Plasma Exchange (Biological)
plasma Exchange+Tenofovir+FMT
Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
干预措施: Tenofovir (Drug)
plasma Exchange+Tenofovir+FMT
Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
干预措施: Fecal Mircobiota Transplantation (Other)
Tenofovir
TabletTenofovir [antiviral] 300mg per oral once a day
干预措施: Tenofovir (Drug)
结局指标
主要结局
Overall survival in both groups
时间窗: Day 28
次要结局
- Reduction in MELD Score in both groups(90 days)
- Percentage of patient's with improvement in hepatic failure calculated by MELD Na.(90 days)
- Percentage of patient's with improvement in hepatic failure calculated by MELD Na(60 days)
- Change in plasma cytokine profile in both groups(60 days)
- Number of patients with adverse Events in both groups(90 days)
- Overall survival in both groups(3 months)
- Reduction in HBV DNA level(90 days)
- Reduction in CTP Score in both groups(90 days)
- Percentage of patient's with improvement in hepatic failure calculated by MELD Na and CTP scores.(14 days)
- Percentage of patient's with improvement in hepatic failure calculated by CTP scores.(90 days)
- Change in microbiota profile in both groups(90 days)