Fecal microbiota transplant for primary prophylaxis of hepatic encephalopathy in patients of liver cirrhosis undergoing transjugular intrahepatic portosystemic shunt: a randomized, sham-controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
研究概览
简要总结
Despite its utility in patients with cirrhosis, TIPSS has its own sets of complications that must be managed effectively to improve the overall outcome. Known complications of TIPSS include cardiac complications, worsening of liver functions and HE. Among, these complications the incidence of HE is highest and is associated with increased morbidity, hospital admissions, and cost of therapy. Studies published in the past decade have reported the incidence of post-TIPSS HE to range from 7% to 61%, and despite clinical and procedural advances there has been no overall trend toward a decrease in incidence of post-TIPSS HE over years.
The pathogenesis of post-TIPSS HE is associated with an abrupt alteration in splanchnic and intrahepatic hemodynamics, along with an increased systemic burden of gut-derived toxins. Gut dysbiosis associated with cirrhosis has an important role in the pathogenesis of post-TIPSS HE. Patients undergoing TIPSS have hepatopetal blood flow towards the low-pressure shunt rather than liver parenchyma whereas the intrahepatic portal vein blood flow is hepatofugal and towards the shunt. As a result of this, there is shunting of ammonia and gut-derived toxins into the systemic circulation leading to an acute rise in ammonia and risk of post-TIPSS HE.
At present the standard of care for post-TIPSS HE includes Lactulose, Rifaximin and L-ornithine L-aspartate but there is an unmet need of therapeutic options for the prevention of P-TIPSS HE. Therefore, in this RCT we plan to evaluate the role of FMT as a primary prophylaxis for HE development in cirrhosis patients undergoing TIPS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Cirrhosis patients undergoing TIPSS for any indications
- •Willing and able to comply with the FMT regimen and all other study requirements
- •Written informed consent.
排除标准
- •Age greater than 75 years
- •Pregnant or lactating woman
- •People living with HIV
- •Patients with low ejection fraction EF less than 50 percent
- •Those undergoing rescue or pre-emptive TIPS for variceal bleed • Patients with severe TR, severe PAH mean Pulmonary Artery Pressure greater than 45 mmHg • Active sepsis • Polycystic liver disease • Biliary obstruction • Patients with history of congestive heart failure • Patients with Chronic Kidney disease eGFR less than 60 ml per min per 1.73m2 for greater than 3 months • Model for End-stage Liver disease score greater than 18 • Patients with acute-on-chronic liver failure ACLF as defined by the European Association for Study of the Liver • Patients with hepatocellular carcinoma • Refusal to give consent • Concurrent diseases which would require use of antibiotics • Patients with history of overt or persistent HE • Any other known neurological disorders • Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study e.g., concurrent malignancies, history of unstable angina, myocardial infarction, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc • Any contraindication for TIPS.
研究者
Dr Shalimar
All India Institute of Medical Sciences