67 Clinical Trials for Various Conditions
This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.
Hepatic Encephalopathy, Cirrhosis
This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors. In essence, this trial aims to deepen understanding of the factors influencing participation in hepatic encephalopathy clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.
Hepatic Encephalopathy
Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes. This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.
Cirrhosis, Hepatic Encephalopathy
This study is being done to assess the safety and efficacy of using mobile application-based Bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.
Hepatic Encephalopathy
This is an observational study that will test the clinical significance of speech features in patients with cirrhosis. It aims to assess if speech is associated with cognitive function at baseline, if speech predicts changes in cognition, and if speech predicts future events of hepatic encephalopathy (cirrhosis-related confusion), as well as to assess the dynamics of speech over time, especially with episodes of overt hepatic encephalopathy (OHE) and treatment interventions.
Hepatic Encephalopathy
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.
Hepatic Encephalopathy
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy. Eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study. The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.
Cirrhosis, Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
Hepatic Encephalopathy
This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention. Patients will be enrolled from the University of Michigan and will complete the baseline assessments in-person or remotely. In addition participants will complete study related materials before, during and after treatment with medically-tailored meals (MTM). After completing the study meals, participants will return for follow-up or have this visit completed remotely as well as have an observational period for 12 more weeks.
Cirrhosis, Ascites, Liver Diseases, Frailty, Sarcopenia, Hepatic Encephalopathy
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.
Hepatic Encephalopathy, Cirrhosis, Liver
There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients
Hepatic Encephalopathy
Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.
Hepatic Encephalopathy, Cirrhosis, Liver
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.
Hepatic Encephalopathy
This is a randomized double-blind placebo-controlled trial of MHE in patients with cirrhosis using rifamycin SV-MMX 600mg BID vs placebo for 30 days with PK, safety, microbiota, brain function and brain MRI endpoints.
Hepatic Encephalopathy, Cirrhosis, Liver
Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of care treatments. Repeated episodes of confusion can make it difficult for patients to function and may result in multiple admissions to the hospital and burden on the family. The investigators have studied using a healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in small studies with good results. In this trial the investigators propose to perform these procedures using an upper and lower route in Veterans who suffer from this condition and follow them for safety and HE and related hospitalizations over 6 months. The investigators will compare this to placebo treatments and hope that this intervention can improve the health and daily functioning of affected patients.
Cirrhosis, Hepatic Encephalopathy
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use. Participants will be adults with liver disease that has affected the brain in the past.
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
Patients with continued cognitive impairment after episodes of HE have few options beyond lactulose and rifaximin in the US. Therefore using IV albumin in a randomized, double-blind, placebo-controlled trial, which could beneficially impact inflammation, could be an additional approach to improve cognition. This 6 week trial will study changes in cognition, HRQOL and inflammation in patients with covert HE after prior overt HE using multiple IV albumin infusions vs. placebo.
Cirrhosis, Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Covert Hepatic Encephalopathy
Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).
Overt Hepatic Encephalopathy
A common complication of advanced liver disease is a condition called hepatic encephalopathy, which leads to confusion. The current treatment options cause side effects, are costly, and do not always work. An abnormal population of bacteria in the intestines may be causing this condition, and transplanting bacteria from the colon of a healthy person may treat it. In this research study, the investigators will first find two healthy stool donors whose stool donation improves the gut bacteria of patients with advanced liver disease and helps them think more clearly. Then, in a randomized controlled trial, the investigators will compare the ability of stool donation from these two best donors versus a placebo to improve the neurological function of patients with advanced liver disease. If the investigators find the expected results, there will be a new effective therapy for patients with advanced liver disease and the very troublesome complication of hepatic encephalopathy.
Hepatic Encephalopathy
Randomized, open-label safety, tolerability study with exploratory endpoints and pathophysiological evaluation of the FMT Two groups of outpatients with cirrhosis will be randomized using random sequence generator into no-treatment and FMT groups.
Hepatic Encephalopathy, Cirrhosis
To see if using ipod games can improve mental functioning
Hepatic Encephalopathy, Cirrhosis
Investigating the impact of hepatic encephalopathy on default mode networks within the brain to provide more clues with understanding the physiology of consciousness and predicting the reversibility of comatose states.
Hepatic Encephalopathy, Cirrhosis, Nonalcoholic Steatohepatitis, Hepatitis C
The purpose of this study is to test feasibility of measuring flumazenil-induced changes in cortical GABA levels observed with localized 1H-MRS in relation to changes in severity of hepatic encephalopathy (HE) in subjects with non-alcoholic liver cirrhosis. This study is a double-blind, placebo-controlled, randomized, cross-over design.
Hepatic Encephalopathy, Liver Cirrhosis
Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also predispose patients to HE. The aim of the present study is to assess if both the OGC and psychometric tests can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of HE. The role of muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be investigated.
Refractory Ascites, Hepatic Hydrothorax, Hepatic Encephalopathy, Cirrhosis
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.
Hepatic Encephalopathy, HE, Cirrhosis, Altered Mental Status, AMS
Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication of acute or chronic liver diseases such as cirrhosis. Due to the diseased liver's inability to remove toxins such as ammonia, which is produced in the gastrointestinal tract, the ammonia accumulates in the brain and causes forgetfulness, confusion, disorientation, concentration and memory problems, changes in mood, decreased alertness and responsiveness, changes in sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable movements, agitation. This study will examine music as a possible external factor that could contribute to impairment in attention and progressive memory in cirrhotic patients while driving. Sustaining attention is important for learning and remembering new information, for e.g. keeping the car within lane and paying attention to cyclists and pedestrians. Prospective memory is the ability to remember to perform previously intended tasks at the appropriate time or occasion, for instance remembering the correct exit while driving on the highway. Impairment in any of these areas may result in serious consequences for patient with cirrhosis. There is evidence that some subsets of cirrhotic patients have a diminished ability to drive and significantly more motor vehicle crashes and traffic violations. In these patients, listening to music while driving may further jeopardize their driving ability, which in turn may lead to reduced quality of life and increased medical costs (from motor vehicle accidents). This is a cross-sectional study designed to determine if there is any effect of listening to music on attention and prospective memory in patients with cirrhosis. For these purposes, subjects will be asked to come for one study visit, which will last approximately 2 hours. During this visit, subjects will undergo a series of screening procedures (consent, assignment of subject identification number, demographics, medical history, physical examination, vitals, height, weight, and eligibility assessment). If they are found eligible, subjects will undergo several neuropsychological assessments to measure any effect of music on attention and prospective memory. These assessments include including Number Connection Test (NCT), Digit Symbol Test (DST), Cambridge Prospective Memory Test (CAMPROMPT) and Inhibitory Control Test (ICT).
Cirrhosis, Hepatic Encephalopathy
This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test patients with cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to decreased bacterial overgrowth. Subjects' mental capacity will be assessed at each visit via interview, brief mental status, questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness, concentration, or understanding of evaluation, will be discontinued from the study. Female subjects of childbearing potential will be asked to comply with the use of contraception during the Phase B study period as well as throughout the time they remain on study drug.
Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Hepatic Encephalopathy
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
Hepatic Encephalopathy, Cirrhosis