[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcoholic-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcoholic-liver-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,70,100,124,146,170,192,219,252,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100393252","study-of-alcohol-related-liver-disease-in-europe-100393252",false,"NCT04400604","Study of Alcohol-related Liver Disease in Europe","Evaluation of the Natural History of Alcoholic Liver Disease According to Baseline Severity","SALVE","Inclusion Criteria:\n\n* Active alcohol excessive consumption defined as \\> 210 g per week for men and\\> 140 g per week for women during the previous year.\n* Patients with high risk of alcoholic-related liver disease can be included only if the following assessment were available: Abdominal Ultrasound \u002F Ultrasound elastography pulse (FibroScan®) \u002F FibroTest®, AshTest® and LCR1-LCR2® (cost will be supported by Biopredictive) \u002F Non-patented methods: Forns Index; Fib-4, Hepascore®\u002F Absolute values should be provided for all these methods.\n\nFor patient in whom liver stiffness measurements were uninterpretable (unavailable results) only those with FibroTest® and LCR1 and LCR2 measurements can be included.\n\nResults of FibroScan® were considered unavailable based on following criteria: When no value was obtained after at least 10 shots (valid shot=0) OR If SR (Success Rate), the ratio of valid shots to the total number of shots at least 60% OR IQR (InterQuartil Range reflecting variability of measurements) less than 30% of the median LSM (Liver Stiffness Measure) value (IQR≤LSM≤30%).\n\n* Patients must provide written informed consent and agree to have blood stored for the study and tissue stored for those in whom physicians performed liver biopsy according their clinical practice.\n* Patients should agree to participate for at least 5-year follow-up.\n* Patients with social insurance\n\nExclusion Criteria:\n\nFor all study groups, the following exclusion criteria will be applied:\n\n* Evidence of other forms of known chronic liver disease including:Positive test result at baseline for hepatitis B surface antigen or positive serology of hepatitis C virus infection (regardless PCR results)\u002F Autoimmune liver disease \u002F Known or suspected HCC\n* Any previous episode of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding before current hospitalization and\u002For inclusion in the study\n* Known positivity for human immunodeficiency virus infection.\n* Terminal extrahepatic illness defined as: All conditions evolved into a clinical stage to limit the patient's functional status (e.g.: heart failure, renal failure, neurological or respiratory diseases, or any other disabling diseases etc. …).\n* Other medical conditions that may diminish life expectancy to \\\u003C2 years.\n* Known extra-hepatic cancers with the exception of basal cell skin cancer.\n* Any other condition that, in the opinion of the Investigator, would impede completion of the study (eg: Homeless, non-compliant patients…).\n* Mental instability or incompetence, such that the validity of informed consent is uncertain.\n* Lack of informed consent or refusal to participate for follow up evaluation.\n* A condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.\n* Pregnant or lactating women","ALL","18 Years","75 Years",{"count":21,"type":22},7500,"ESTIMATED","OBSERVATIONAL","Alcohol-induced liver injury is made up of fatty liver, fibrosis and alcoholic hepatitis (AH), elementary lesions that may occur separately, simultaneously or sequentially in a same patient. Among these histological features, alcoholic hepatitis, a necro-inflammatory process is associated with the fastest fibrosis progression leading to cirrhosis in 40% of cases and a pivotal lesion driving increased risk of liver decompensation.\n\nThe non-invasive methods for the diagnosis of fibrosis open new perspectives for a better understanding of the natural history of disease-progression from early injury to the cirrhotic stage, for the identification of subgroup patients at risk of developing cirrhosis at medium term and for proposing a strategy of screening of patients with extensive cirrhosis at risk of liver-threatening events. There is an urgent need to perform studies in asymptomatic heavy drinkers in order to identify cut-offs associated with significant risk of development of cirrhosis at medium term. Such objectives require large-scale screening of heavy drinkers. Each of non-invasive methods have been tested to predict with of extensive fibrosis with a high predictive performance as shown below.\n\nA screening policy cannot be accepted without answering the following questions: a) are the requirements of public health screening fulfilled? b) Is the group of patients undergoing screening defined? c) is there a reliable method for of testing? Indeed, the detection of a disease is subject to certain public health requirements and may be proposed to health authorities only if it modifies the management of subjects screened. In the specific case of mass screening of liver fibrosis in heavy drinkers, only the detection of extensive fibrosis could fulfill this criterion because of the potential survival benefit resulting from the screening of hepatocellular carcinoma (HCC) in patients with extensive fibrosis. Indeed, recent studies have found that the probability of receiving curative treatment of HCC was significantly higher in patients who received a six-month surveillance ultrasound. Therefore, the detection of extensive fibrosis seems reasonable in the light of these studies when considering that the yearly risk of development of HCC in the subgroup of heavy drinkers with extensive fibrosis is approximately 3%.\n\nTaking into account the above scientific arguments, the most recent EASL clinical practical guidelines on ALD recommend longitudinal studies using non-invasive tools to evaluate screening of extensive fibrosis and disease progression in heavy drinkers.",[26],"Alcoholic Liver Disease","RECRUITING","2026-05-20",{"date":30,"type":31},"2026-05-22","ACTUAL",{"date":33,"type":31},"2021-03-03",{"date":35,"type":22},"2032-03",{"name":37,"class":38},"University Hospital, Lille","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":23,"phases":4,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100370681","study-of-genetic-determinants-in-alcoholic-hepatitis-and-establishment-of-a-multicenter-prospective-cohort-of-patients-with-alcoholic-liver-disease-100370681","NCT04106518","Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease","COMADHAA","Inclusion Criteria:\n\nFor SAH group:\n\n* Alcohol consumption :\n\n  * On average\\> 40 g \u002F day for women and 50 g \u002F day for men\n  * Duration:\\> 5 years\n* Recent jaundice episode (less than 3 months)\n* Bilirubin\\> 50 mg \u002F l (85μmol \u002F l)\n\nFor NSAH group:\n\n\\- Alcohol consumption :\n\n* On average\\> 40 g \u002F day for women and 50 g \u002F day for men\n* Duration:\\> 5 years\n\nFor cirrhosis (control) group:\n\n* Alcohol consumption :\n\n  * On average\\> 40 g \u002F day for women and 50 g \u002F day for men\n  * Duration:\\> 5 years\n* Unambiguous presence of cirrhosis criteria, including:\n\n  * clinical signs (ascites, stellar angiomas ...) and \u002F or\n  * radiological signs (scanner or MRI: signs of hepatic dysmorphism and \u002F or portal hypertension) and \u002F or\n  * biological signs (increased INR, thrombocytopenia) and \u002F or\n  * endoscopic signs (oesophageal \u002F gastric varices)\n\nExclusion Criteria:\n\nFor NAH and NSAH groups:\n\n* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)\n* Presence of hepatocellular carcinoma\n* HIV infection\n\nFor cirrhosis (control) group:\n\n* History established \u002F suggestive of HAA (Clinical, biological and \u002F or histological criteria) in particular absence of jaundice episode\n* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)\n* Presence of hepatocellular carcinoma\n* HIV infection",{"count":48,"type":22},447,"5 Years","Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.",[26,52,53],"Severe Alcoholic Hepatitis","Alcoholic Cirrhosis",[55,56,57,58,59,60],"Cohort","alcoholic hepatitis","alcoholic cirrhosis","pathophysiology","bio bank","pan-genomic study","2026-05-18",{"date":63,"type":31},"2026-05-19",{"date":65,"type":31},"2019-10-23",{"date":67,"type":22},"2027-04",{"name":37,"class":38},9,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":39},"100539755","intra-hepatic-microbiota-in-alcoholic-hepatitis-100539755","NCT06307964","Intra-Hepatic Microbiota in Alcoholic Hepatitis","HepMAH","Inclusion Criteria:\n\n* Patients suffering from alcoholic liver disease and clinical suspicion of alcoholic hepatitis (subacute jaundice, heavy alcohol consumption active or weaned for ≤ 3 months, modified Maddrey score ≥32) and indication for diagnostic transjugular liver biopsy;\n* Non-objection obtained from the patient or trusted person in case of impaired judgment or consciousness before performing liver biopsy;\n* Aged ≥ 18 years at the time of study entry;\n\nExclusion Criteria:\n\n* Patients who were treated with antibiotics or probiotics between the 15th day and 72 hours prior to liver biopsy, with the exception of antibiotics used for the prophylaxis of ascites infection or hepatic encephalopathy\n* Contraindication to transjugular liver biopsy (hepatocellular carcinoma on predicted puncture site)\n* Pregnant, parturient or breast-feeding women\n* Persons deprived of their liberty by judicial or administrative decision\n* Adults under legal protection (guardianship, curators)",{"count":78,"type":22},50,"Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease.\n\nNumerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.\n\nThe study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.\n\nThe aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group \"alcoholic liver disease with no AH\", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.\n\nThis exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA.",[81,26,82],"Cirrhosis","Alcoholic Hepatitis",[84,85,86,87,88,89,90],"alcoholic hepatis","bacterial translocation","microbiota","16S rRNA","intra-hepatic microbiota","cirrhosis","alcoholic liver disease","2026-02-06",{"date":93,"type":31},"2026-02-10",{"date":95,"type":31},"2024-07-23",{"date":97,"type":22},"2028-07-23",{"name":99,"class":38},"Hospices Civils de Lyon",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":39},"100413654","integrated-diagnostics-for-early-diagnosis-of-liver-disease-100413654","NCT04666402","Integrated Diagnostics for Early Diagnosis of Liver Disease","ID LIVER","Inclusion Criteria:\n\n* All patients referred to Community Liver Assessment Clinic.\n* Male or female \\> 18 years of age.\n* Females will be non-pregnant and non-lactating.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy\u002Fbreast-feeding. Women of childbearing potential (not \\>2 years post- menopausal and\u002For not surgically sterilised) must have a negative blood serum pregnancy test.\n* Isolated bilirubinaemia.\n* Known pre-existing liver disease.\n* Acutely unwell.\n* Suspected malignancy.",{"count":108,"type":22},1200,"This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.",[111,112,26,113],"Non-Alcoholic Fatty Liver Disease","Non-alcoholic Steatohepatitis","Liver Fibroses","2026-02-05",{"date":116,"type":31},"2026-02-09",{"date":118,"type":31},"2020-10-21",{"date":120,"type":22},"2027-03-31",{"name":122,"class":123},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":39},"100301875","ethanol-induces-skeletal-muscle-autophagy-100301875","NCT03209791","Ethanol Induces Skeletal Muscle Autophagy","Mechanisms of Skeletal Muscle Proteolysis With Ethanol Consumption: an Integrated Molecular Metabolic Approach","Inclusion Criteria:\n\nAlcoholic liver disease:\n\n* clinical, biochemical, imaging criteria and liver biopsy where available\n* Age 18 - 65 years old\n\nControls:\n\n* Serum liver transaminases (i.e. ALT and AST) 40 IU\u002FL\n* Normal liver ultrasound\n* Age 18 - 65 years old\n\nExclusion Criteria:\n\nFor both groups - alcoholic liver disease and controls:\n\n* Poorly controlled diabetes mellitus (HbA1C\\>9.5 g\u002Fdl)\n* Untreated Hyper- \u002F hypo- thyroidism\n* Patients on dialysis, renal disease with serum creatinine 1.5 mg\u002FdL\n* Active intravenous drug use\n* History of bowel surgery or gastric bypass surgery\n* Medications known to alter muscle protein metabolism (i.e. corticosteroids, tamoxifen, high-dose estrogen, testosterone or anabolic steroids)\n* Metastatic disease, Advanced cardiac or pulmonary disease\n* Pregnancy\n* Coagulopathy- INR \\>1.4 and platelet count \\\u003C80,000\u002Fml.",true,"65 Years",{"count":134,"type":22},40,"In this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade MAA adducts.",[26],"2026-01-08",{"date":139,"type":31},"2026-01-09",{"date":141,"type":31},"2015-05-18",{"date":143,"type":22},"2027-12-31",{"name":145,"class":38},"The Cleveland Clinic",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":153,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":39},"100428390","study-of-hmb-enriched-amino-acid-supplementation-in-patients-with-alcoholic-liver-disease-and-covid-19-100428390","NCT04858412","Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19","Evaluate the Molecular Mechanisms of HMB-enriched Amino Acid Supplement to Reverse Muscle Loss in Patients With Alcoholic Liver Disease and COVID-19","Inclusion Criteria:\n\nA. Cases: Patients with ALD and COVID-19 pneumonia:\n\n1. Clinical, imaging, laboratory, and\u002For histological diagnosis of alcoholic cirrhosis and\u002For alcoholic hepatitis\n2. Child Pugh score 5-8, serum creatinine \\\u003C3, Model for End Stage Liver Disease score (MELD) \\\u003C25\n3. Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 \\\u003C93% or on oxygen supplement\n4. Age of 21 years or older\n\nB. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:\n\n1. Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 \\\u003C93% or on oxygen supplement\n2. Age of 21 years or older\n\nExclusion Criteria: (Both Cases and Controls)\n\n1. Patients requiring active ventilator support\n2. Anticoagulant\u002Fantiplatelet therapy (for those in the biopsy arm, see Randomization schema. If clinically feasible, patients will be asked to hold their anticoagulants for the muscle biopsy after physician review),\n3. Recent gastrointestinal bleeding (\\\u003C3 months)\n4. Advanced organ diseases: congestive heart failure (NYHA class 3 and 4), chronic obstructive pulmonary diseases (COPD) (GOLD stage 3 and 4), chronic kidney disease (Cr\\>3), metastatic malignancy\n5. Medications that alter muscle protein metabolism except systemic corticosteroids\n6. Pregnancy\n7. Unwillingness\u002F Inability to sign informed consent","21 Years",{"count":155,"type":22},48,"INTERVENTIONAL",[158],"NA","Patients with COVID-19 and comorbidities including alcohol associated liver disease (ALD) are at risk for severe illness and abrupt or sudden clinical deterioration with ventilatory failure. â-hydroxy â-methyl butyrate (HMB), a non-nitrogenous leucine metabolite with anabolic properties, increases muscle mass and contractile function and enhances immune function. We aim to study the natural course of COVID-19 in patients with ALD and test whether HMB can affect ventilatory deterioration and improve short and long-term morbidity, mortality, and recovery from critical illness in symptomatic COVID-19 patients with ALD.",[26,161],"COVID 19 Pneumonia","2025-11-24",{"date":164,"type":31},"2025-11-25",{"date":166,"type":31},"2021-04-01",{"date":168,"type":22},"2026-12-31",{"name":145,"class":38},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":131,"sex":17,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":156,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":39},"100387089","effect-of-fermented-protaetia-brevitarsis-seulensis-powder-on-alcohol-induced-liver-disease-100387089","NCT04320199","Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease","Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit\n\nExclusion Criteria:\n\n* Abnormal liver or renal function (i.e., serum aminotransferase activity \\> 3 times of upper limit of reference range and serum creatinine concentrations \\> 1.2 mg\u002FdL)\n* Diabetes (diagnosed clinically or fasting glucose level \\> 126 mg\u002FdL)\n* History of viral hepatitis or cancer\n* Uncontrolled hypertension\n* History of serious cardiac disease such as angina or myocardial infarction\n* History of gastrectomy\n* History of medication for psychiatric disease\n* Administration of oriental medicine including herbs within the past 4 weeks","19 Years",{"count":179,"type":22},30,[158],"The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.",[26],"2025-06-01",{"date":185,"type":31},"2025-06-04",{"date":187,"type":31},"2020-01-01",{"date":189,"type":22},"2025-12-31",{"name":191,"class":38},"Pusan National University Yangsan Hospital",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":39},"100508091","french-national-micmaf-cohort-100508091","NCT05895890","French National MICMAF Cohort","Study of the Evolution of the Intestinal Microbiome (Taxonomic and Functional Composition) During Alcoholic Liver Disease","MICMAF","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Average alcohol consumption of more than 20 g per day in women and 30 g per day in men during the previous year;\n* Patients seen in consultation or hospitalized for assessment of alcoholic liver disease and management of alcohol addiction;\n* Having given their consent to participate in this study;\n* Affiliated to a social security system (beneficiary or beneficiary's right).\n\nExclusion Criteria:\n\n* Antibiotic, probiotic or prebiotic treatment within the previous 3 months ;\n* Digestive hemorrhage, acute pancreatitis, acute or chronic diarrhea (except diarrhea related to excessive alcohol consumption) or chronic inflammatory bowel disease;\n* Another cause of liver damage;\n* A serious associated pathology (respiratory failure, heart failure, severe psychiatric disorders, active cancer).\n* Patient under guardianship or curatorship",{"count":201,"type":22},1000,"Excessive alcohol consumption is a major public health problem, particularly in France. It is the leading cause of cirrhosis and hepatocellular carcinoma. Among subjects with heavy alcohol consumption, the majority of patients develop fatty liver overload (steatosis), but only 10 to 35% develop acute alcoholic hepatitis (AAH) and 8 to 20% progress to cirrhosis. Steatosis is the earliest lesion, rapidly reversible after abstinence from alcohol. On the other hand, the occurrence of AAH leads to a strong progression of fibrosis. The investigators have shown on serial liver biopsies that a subgroup of heavy drinkers develop episodes of AAH and progress to cirrhosis. Therefore, factors other than the amount of alcohol consumed alone influence the development and progression of alcoholic liver disease (ALD). Among these factors, it is now accepted that the gut microbiome plays an important role in the pathogenesis of ALD. Increased intestinal permeability and activation of the innate immune system by lipolysaccharide (LPS) of digestive origin is a key factor in the initiation of AAH. The alteration of the intestinal barrier induced by alcohol abuse seems to involve dysbiosis. Furthermore, the investigatorshave shown that the sensitivity of the liver to alcohol toxicity is transmissible from humans to mice via the gut microbiome. Despite these advances, the causal relationship between mycobiome disruption and ALD in humans requires confirmation in prospective studies.\n\nThe intestinal microbiome represents all the microorganisms found in the digestive tract: bacteria (bacterial microbiome), viruses (virome), fungi (mycobiome).\n\nRecent data point to the role of disturbances of the mycobiome and the virome in human pathology. The intestinal virome consists of two major types of viruses: eukaryotic RNA and DNA viruses that infect host cells and prokaryotic or bacteriophage viruses that infect the bacterial microbiome. Recent evidence suggests that the virome participates in immune system homeostasis. Infection of axenic mice with murine norovirus restores the functionality of intestinal lymphocytes. However, the involvement of the intestinal virome in ALD has never been studied.\n\nCessation of alcohol consumption has a beneficial effect in all stages of ALD . It reduces the risk of complications of cirrhosis and, for early stages of liver damage, prevents progression to advanced stages (severe AAH and cirrhosis). Unfortunately, most patients with alcohol addiction do not achieve long-term abstinence or significant reduction in their consumption despite psychological and medical support. Depression and anxiety are also associated with gut dysbiosis in humans. The causal role, at least partial, of this dysbiosis in addictive phenomena, whether alcohol or other addictions such as cocaine, has been shown. Thus, the modification of MI influences the addictive behavior of cocaine-dependent mice (. All these data show the major role of the microbiota-central nervous system (CNS) axis in mental disorders such as alcohol addiction and its consequences (craving, depression, anxiety). This interaction is mediated by several mechanisms such as the production of active metabolites by the intestinal microbiome and the translocation of bacteria or bacterial derivatives.\n\nPrimary Objective:\n\nTo characterize temporal changes in the gut microbiome (bacterial, viral, and fungal) within sequential specimens (stool, saliva, serum) prior to the occurrence of acute alcoholic hepatitis episodes\n\nSecondary Objectives:\n\n* Demonstrate that specific fecal, serum, or saliva microbiome profiles (bacterial, viral, and fungal) can predict the progression of alcoholic liver disease to severe alcoholic hepatitis, fibrosis, and cirrhosis.\n* Characterize changes in the composition of the gut microbiome (bacterial, viral and fungal) associated with the progression of alcoholic liver disease to severe alcoholic hepatitis and cirrhosis.\n* Characterize the changes in the microbiome during alcohol withdrawal.\n* Identify microbiome profiles associated with alcohol dependence and anxiety-depressive events related to alcohol addiction.\n* To identify bacterial species with a protective effect in alcoholic liver disease.\n* To identify beneficial bacterial species against alcohol dependence.\n* To study the microbiome-host interaction in alcoholic liver disease and alcohol addiction.\n* To identify microbiome profiles with prognostic value in severe alcoholic hepatitis and alcoholic cirrhosis.\n\nNumber of centers: 7 Number of subjects expected 1000 Population concerned: The study will include a population of patients with excessive alcohol consumption seen in consultation or hospitalized for alcohol addiction problems and\u002For exploration of alcohol-related liver damage Inclusion period: January 2020 - January 2030 Patient observation period: 5 to 20 years Study duration: 30 years",[26],[205,206,207,208,209],"Alcoholic","Liver Disease","Intestinal microbiome","Addiction","Depression","2023-07-05",{"date":212,"type":31},"2023-07-06",{"date":214,"type":31},"2022-10-01",{"date":216,"type":22},"2053-02-01",{"name":218,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":156,"phases":229,"briefSummary":230,"conditions":231,"keywords":237,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100504953","the-liver-care-trial-100504953","NCT05855031","The Liver Care Trial","The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study","Inclusion Criteria:\n\n* Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde\n* Informed written consent\n\nExclusion Criteria:\n\n* Not speaking Danish or English\n* Severe liver disease (known by the participant)","110 Years",{"count":228,"type":22},408,[158],"The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units\u002Fweek) throughout the last months, and assessed 6 months after randomization.",[26,232,233,234,235,236],"Alcohol Use Disorder","Alcohol Abuse","Alcoholism","Fibrosis, Liver","Alcohol-Related Disorders",[238,239,240,241],"Screening","Fibroscan","Liver stiffness measurement","abstinence","2023-05-15",{"date":244,"type":31},"2023-05-17",{"date":246,"type":31},"2023-05-08",{"date":248,"type":22},"2027-05-01",{"name":250,"class":38},"Zealand University Hospital",2,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":259,"targetDuration":261,"studyType":23,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":39},"100306272","evaluating-alcohol-use-in-alcoholic-liver-disease-100306272","NCT03267069","Evaluating Alcohol Use in Alcoholic Liver Disease","Inclusion Criteria:\n\n* alcoholic liver disease able to consent\n\nExclusion Criteria:\n\n* without alcoholic liver disease unable to consent","80 Years",{"count":260,"type":22},160,"10 Years","This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.",[26],"2019-03-11",{"date":266,"type":31},"2019-03-13",{"date":268,"type":31},"2016-11-27",{"date":270,"type":22},"2027-11-01",{"name":272,"class":38},"Nicole T Shen",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":156,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":284,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":39},"100324415","herbal-supplements-for-improvement-of-liver-function-in-participants-with-alcoholic-liver-disease-100324415","NCT03503708","Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease","Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study","Inclusion Criteria:\n\nAdults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:\n\n* Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire\n* Active alcohol use until 4 weeks prior to presentation\n* ALT and AST elevated \\>1.5 times the upper limit of normal\n* Over 1.5 ratio of AST to ALT\n* Maddrey Discriminant function(DF) less than 30\n\nExclusion Criteria:\n\n* Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months\n* Severe renal impairment (Glomerular filtration rate below 60 ml\u002Fmin per 1.73m2)\n* Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease\n* Participants with active viral hepatitis\n* Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry\n* Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.\n* Pregnant, attempting to conceive, or lactating women\n* Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.",{"count":134,"type":22},[158],"Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.",[26],"NOT_YET_RECRUITING","2018-04-19",{"date":287,"type":31},"2018-04-20",{"date":289,"type":22},"2018-05-30",{"date":291,"type":22},"2028-11-30",{"name":293,"class":294},"Composite Interceptive Med Science","INDUSTRY"]