View clinical trials related to Hepatic Encephalopathy.
Filter by:Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
The aim of this study is to compare the efficacy and safety of colistin versus lactulose for secondary prophylaxis of overt hepatic encephalopathy in patients with liver cirrhosis.
Despite standard of care, the recurrence of hepatic encephalopathy remains the primary cause for readmissions in individuals with cirrhosis. Patients with cirrhosis have disturbed gut microbiota, which is exacerbated by repeated antibiotic usage. FMT is a promising therapy to restore a healthy microbiota. FMT causes change in composition of gut microbiota which will lead to increase in commensal bacterial diversity which will increase colonization resistance to pathogenic bacteria and thereby decrease the bacterial overgrowth. Healthy bacteria also increase the SCFA production in colon with is and nutrient for endothelial cells and thereby protect the endothelial integrity and decreases bacterial translocation and endotoxemia. Current standard of care mainly focuses on the treatment of precipitating factors of the HE. The goal of our open-label, randomised clinical trial is to evaluate the safety, efficacy of addition of FMT to SOC in preventing subsequent episodes of hepatic encephalopathy.
TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiology of HE. Polydextrose (PDX) is consider as a prebiotic. Preliminary studies showed that PDX: 1. modified gut microbiota, enhancing "good bacteria" 2. improved gut permeability and immunity in 2 experimental models: infarction and colitis. The aim of this study is to assess PDX efficacy to prevent HE during the first 6 months after TIPS in cirrhotic patients.
Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged. The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed. Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)
Hepatic encephalopathy (HE) is a common complication of cirrhosis, which seriously damages the life quality of patients. As the disease progresses, 50-80% of patients with cirrhosis develop HE. Minimal hepatic encephalopathy (MHE) is a manifestation of HE, in which the patient usually has no obvious clinical symptoms and can only be detected by neuropsychological testing. Early identification and timely treatment are the keys to improve the prognosis of HE, and the diagnosis of MHE are the priority in the process of the disease intervention. Guidelines in many countries suggest that MHE does not recommend routine treatment. However, patients with cirrhosis usually have complex clinical complications, so whether timely treatment should be taken remains to be explored. The purpose of this study is to investigate the incidence of MHE in cirrhotic patients, and to establish a real-world cohort for further study on drug therapy and efficacy evaluation.
Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a very effective treatment. However, due to the severe complications such as hepatic encephalopathy after TIPS, the clinical application of TIPS is limited. Literature studies have shown that the incidence of encephalopathy after TIPS is about 35%. TIPS reduces the portal vena blood flow into the liver by establishing a new channel. But at the same time, the toxic substances from the gastrointestinal tract and other organs do not enter the liver to detoxify, and are more likely to enter the brain, leading to hepatic encephalopathy. Moreover, studies have found that the liver and the intestine originate from the same germ layer and are closely related to each other in anatomy and function. There are a large number of microorganisms living in the intestinal tract. Normally, the intestinal tract, as the first defense of the human body, can effectively prevent bacteria and their products from entering the bloodstream. In cirrhosis and portal hypertension, blood return disorder causes intestinal damage. A series of microbes and product endotoxins such as gram-negative bacteria will enter the blood through the injury, and the toxins in the peripheral blood will enter the brain and cause hepatic encephalopathy happened. The research team's early treatment plan with integrated traditional Chinese and Western medicine proved that it greatly reduced the incidence of hepatic encephalopathy after TIPS. And improve the clinical symptoms and signs of patients with liver cirrhosis, and improve the quality of life and survival of patients.
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or discontinue their PPIs to determine whether these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic encephalopathy (HE). Patients will be assessed for symptoms of minimal HE (MHE), using the established psychometric hepatic encephalopathy score (PHES) battery of tests. MHE assessment will be conducted at two timepoints: at baseline prior to randomization and TIPS creation and approximately 4 weeks after randomization and TIPS creation. Stool samples will also be collected at both timepoints to allow characterization of the gastrointestinal (GI) tract microbiome using 16S rRNA sequencing. The pre to post-TIPS change in PHES scores will be compared between patients randomized to continue versus discontinue their PPIs. Quality of life (QOL) will also be assessed. Changes in the GI tract microbiome will be analyzed to determine whether this represents a potential biological mechanism linking PPI use with post-TIPS HE.
The personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. The pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.