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Alcoholic Liver Disease clinical trials

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NCT ID: NCT05428072 Completed - Clinical trials for Alcoholic Liver Disease

Alcohol, Gut Leakiness, & Liver Disease

Start date: January 2003
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to investigate the role of gut leakiness in alcoholic liver disease. Gut leakiness may be the missing susceptibility factor that explains why some alcoholics develop liver disease and others don't. For this study, subjects 480 (240 male, 240 female, ages 18-80) will be recruited. Alcoholic subjects will be recruited from outpatient & inpatient alcohol detoxification units from Rush, Loyola & two halfway houses (one for women, one for men); patients with liver disease from GI/Hepatology Services at Rush, Hines VA Hosp & Loyola University; and controls from hospital staffs. All subjects will fill out a detailed questionnaire, be interviewed by the study coordinator & undergo an exam by the PI to ensure that all inclusion criteria are satisfied. All subjects will have a urine collection for tests of intestinal permeability (urinary sugars). Gut leakiness will be determined by the amount of sugars in the urine.

NCT ID: NCT04557774 Completed - Clinical trials for Alcoholic Liver Disease

Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Start date: October 1, 2011
Phase:
Study type: Observational

Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis

NCT ID: NCT03915002 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Integrated Approaches for Identifying Molecular Targets in Liver Disease

InLi
Start date: June 13, 2019
Phase:
Study type: Observational

To provide a framework for successful clinical trials testing novel targets for therapy in liver disease. To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression. Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.

NCT ID: NCT03402256 Completed - Clinical trials for Alcoholic Liver Disease

Text Messaging to Reduce Alcohol Relapse in Liver Transplant Patients

Start date: March 22, 2013
Phase: N/A
Study type: Interventional

This is a research study of a text-messaging intervention to reduce alcohol relapse risk in pre-transplant liver transplantation patients. This study is an 8-week, randomized controlled pilot trial to investigate the feasibility and acceptability of a text-messaging intervention for alcohol relapse prevention and stress reduction in 20 liver transplant patients with alcohol-related liver disease. The goals of the study are (1) to develop a mobile, SMS-based stress reduction and alcohol use intervention for pre- liver transplant patients with alcohol-related liver disease (ALD) and (2) to evaluate the feasibility and acceptability of the mobile intervention and its effect on rates of alcohol consumption compared to a Standard Care condition in a liver transplantation center.

NCT ID: NCT02796469 Completed - Alcoholic Hepatitis Clinical Trials

Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis

Start date: May 2015
Phase: N/A
Study type: Observational

In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses. The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline. The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.

NCT ID: NCT02381769 Completed - Clinical trials for Alcoholic Liver Disease

THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.

Start date: June 2013
Phase: N/A
Study type: Interventional

The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.

NCT ID: NCT02281929 Completed - Alcoholic Hepatitis Clinical Trials

Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

AntibioCor
Start date: June 13, 2015
Phase: Phase 3
Study type: Interventional

Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint) as compared to corticosteroids alone. The project is based on an approach never tested in a randomized controlled trial in severe alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2 months). This approach is based on animal and human studies.Antibiotics are effective in animal models and in other circumstances characterized by liver failure such as gastrointestinal bleeding related to portal hypertension. The interest of studying this population is emphasized by the frequency of infections in these critically ill patients. Antibiotics will be administered before the development of any infection, as it is likely that these patients present with mesenteric bacterial adenitis without systemic signs of infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and treatment is given for 30 days.

NCT ID: NCT02140294 Completed - Clinical trials for Alcoholic Liver Disease

Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease

Start date: May 2014
Phase: N/A
Study type: Interventional

Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months.

NCT ID: NCT01711125 Completed - Alcohol Dependence Clinical Trials

Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

BacALD
Start date: March 2013
Phase: Phase 3
Study type: Interventional

To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

NCT ID: NCT01504295 Completed - Clinical trials for Alcoholic Liver Disease

A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease

Start date: April 2012
Phase: Phase 2
Study type: Interventional

It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in Europe for acute and chronic alcohol intoxication but has never been tested in the US. Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol consumption and improve liver function is confirmed by a rigorous study design, then MTDX might represent a truly innovative pharmacotherapy for AD, given the potential to be used for AD individuals with ALD. However until this proposal, MTDX has never been investigated as a treatment for AD able to reduce both alcohol consumption and improve alcohol-related liver damage via a double-blind placebo-controlled study. This project therefore proposes to conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled, between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.