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Hepatitis, Alcoholic clinical trials

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NCT ID: NCT02344680 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Start date: October 2015
Phase:
Study type: Observational

In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of antiretroviral drugs in the prevention and/or reduction of liver disease.

NCT ID: NCT02335632 Unknown status - Clinical trials for Alcoholic Liver Disease

Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

NCT ID: NCT02326103 Completed - Alcoholic Hepatitis Clinical Trials

Randomised Open-label Multicenter Study Evaluating Ciprofloxacin in Severe Alcoholic Hepatitis

Start date: April 2015
Phase: Phase 0
Study type: Interventional

The study is aimed to evaluate the additional role of ciprofloxacin therapy in severe alcoholic hepatitis combined to prednisolone therapy in an open-label placebo controlled manner.

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: NCT02275195 Recruiting - Hepatitis Clinical Trials

Immune Cell Dysfunction in Severe Alcoholic Hepatitis

Start date: November 2013
Phase:
Study type: Observational

Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.

NCT ID: NCT02265328 Completed - Clinical trials for Severe Alcoholic Hepatitis in 'Extremis'- Defined by mDF>54

Efficacy of Combination Therapy of Glucocorticoids and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis.

COBS
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF) ≥32, is associated with significant morbidity and mortality. Of the various treatment modalities evaluated for treatment of SAH, corticosteroids have been the most extensively studied. Five out of 13 RCTs, and four out of 5 meta-analysis have shown a survival benefit with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.However, the role of corticosteroids in SAH still remains somewhat controversial. Corticosteroid therapy is not considered the ideal option by all authors because their beneficial effect seems to be confined to a highly selected minority group in which the inhibitory effect of corticosteroids on liver inflammation is not outweighed by side effects such as weakened defence against infections, anti-anabolic effects, and possible ulcer promoting effects. Also corticosteroids are contraindicated in patients with renal failure, gastro-intestinal (GI) bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to evaluate new therapies for SAH. In a recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one month survival in patients with SAH, compared with glucocorticoids alone. However the 6 month survival was not different in both groups. Human Colostrum (HC) and Bovine Colostrum (BC) are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent studies suggest that colostrum components, Lactroferrin, immunoglobulin and growth factor benefits physically active person and in treatment of autoimmune disorders. It is used for the treatment of a wide variety of gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut injury, H pylori infection, immune deficiency related diarrhea as well as infective diarrhea. The guidelines by American College of Gastroenterology and other authors have suggested that a combination of CS and other drugs, which have different mechanisms of action, may be more beneficial for reducing mortality in SAH. Hence, we plan to conduct this pilot study to investigate the efficacy of a novel combination of corticosteroids, and Bovine colostrum in the treatment of SAH.

NCT ID: NCT02172898 Completed - Alcoholic Hepatitis Clinical Trials

Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium

Start date: June 2013
Phase:
Study type: Observational

To conduct a prospective, multicenter, observational study of patients with well-characterized alcoholic hepatitis (AH) and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository will be developed from both cases and controls.

NCT ID: NCT02161653 Completed - Clinical trials for Severe Alcoholic Hepatitis

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

NCT ID: NCT02116556 Enrolling by invitation - Alcoholic Hepatitis Clinical Trials

Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

RIFA-AAH
Start date: April 2013
Phase: Phase 2
Study type: Interventional

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis. The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

NCT ID: NCT02075918 Completed - Alcoholic Hepatitis Clinical Trials

Integrated Approaches for Identifying Molecular Targets in Alcoholic Hepatitis

InTeam
Start date: May 2014
Phase:
Study type: Observational

Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.