Evaluation of Fecal Microbiota Transplantation With or Without Prebiotic Supplementation for Refractory Hepatic Encephalopathy After TIPS Surgery

What this Trial Is About

This research aims to assess the safety and initial effectiveness of fecal microbiota transplantation combined with standard medical therapy in adults with refractory overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt TIPS. It also explores whether adding prebiotic dietary fiber improves clinical outcomes and supports gut microbiota restoration. The study targets patients who continue to experience recurrent hepatic encephalopathy despite treatment with rifaximin and lactulose. Participants will receive standard therapy with rifaximin and lactulose throughout the study. During an overt hepatic encephalopathy episode, all will undergo fecal microbiota transplantation via a nasojejunal tube, given as 100 mL infusions twice daily for three days. Participants are divided into two groups one receiving only fecal microbiota transplantation, and the other also receiving dietary fiber prebiotic supplementation at 24 g daily for four weeks alongside the transplantation and standard therapy. Participants will be followed for six months with scheduled assessments before and after transplantation, including blood tests, stool samples, mental and neurocognitive evaluations, and monitoring of symptoms and adverse events. Researchers will measure recurrence and severity of hepatic encephalopathy, liver and kidney function, inflammatory markers, gut microbiota changes, and safety outcomes. This comprehensive monitoring aims to provide preliminary evidence for a microbiota-based treatment approach in this patient group.

Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery