[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcoholic-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcoholic-cirrhosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,76,103,130,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645066","pomegranate-dietary-supplements-in-aud-and-ald-100645066",false,"NCT07678567","Pomegranate Dietary Supplements in AUD and ALD","Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)","Healthy Group:\n\nInclusion: Healthy individuals, Exclusion: AUD, ALD, AC, and inflammatory conditions,\n\nAlcohol Use Disorder Group:\n\nInclusion: AUD diagnosis Exclusion: alcohol-associated systemic conditions\n\nAlcohol-associated liver disease Group:\n\nInclusion: early-stage ALD comorbid with AUD Exclusion: Only AUD or AUD with AC\n\nAlcohol-associated cirrhosis Inclusion: AC with AUD Exclusion: AUD, and early stage ALD, as well as determined by the study cohort criteria",true,"ALL","18 Years",{"count":20,"type":21},144,"ESTIMATED","OBSERVATIONAL","The goal of this project is to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. Recent publications have reported that urolithins are the major active metabolites responsible for the beneficial effects of eating pomegranates, berries, or walnuts. However, the production of urolithins from the parent compound ellagic acid (EA) is dependent upon the presence of certain bacteria in the human gut. In this trial, we propose to investigate variations in gut microbiota and their capacity to metabolize pomegranate dietary supplements (PDS) into active urolithins. We will measure the levels of urolithins in blood as well as inflammatory cytokines in plasma samples upon consumption of PDS.",[25,26,27,28],"Alcohol Use Disorder","Alcohol-associated Liver Disease","Alcoholic Cirrhosis","Healthy",[30],"Pomeragranate, AUD, ALD","NOT_YET_RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":21},"2027-01-01",{"date":39,"type":21},"2032-12-31",{"name":41,"class":42},"University of Louisville","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"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":52,"type":21},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.",[56,57,27],"Alcoholic Liver Disease","Severe Alcoholic Hepatitis",[59,60,61,62,63,64],"Cohort","alcoholic hepatitis","alcoholic cirrhosis","pathophysiology","bio bank","pan-genomic study","RECRUITING","2026-05-18",{"date":68,"type":35},"2026-05-19",{"date":70,"type":35},"2019-10-23",{"date":72,"type":21},"2027-04",{"name":74,"class":42},"University Hospital, Lille",9,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100381719","phase-2-same-trial-for-patients-with-alcoholic-cirrhosis-100381719","NCT04250259","SAMe Trial for Patients With Alcoholic Cirrhosis","A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis","Inclusion criteria for patients with alcoholic cirrhosis\n\n1. Evidence of cirrhosis as per clinical signs and\u002For noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and\u002For histopathology by biopsy and\n2. subjects with clinical presentation either in Child Class A or B at the time of enrollment\n3. individuals 18 to 70 years old and may or may not consume alcohol during study.\n\nInclusion criteria for healthy control :\n\n) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink \\\u003C 50 grams per day on average in women and \\\u003C 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.\n\nExclusion criteria for patients with alcoholic cirrhosis\n\n1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia,\n2. Known co-existing infection with hepatitis C, hepatitis B, or HIV\n3. Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study\n4. Gastrointestinal bleeding within the prior 28 days3\n5. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening\n6. Women who are pregnant, may become pregnant, or nursing\n7. Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery\n8. Subjects with history of\u002Fdiagnosis of hepatocellular carcinoma\n9. Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study\n10. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and\n11. Subjects who are immunocompromised\n\nExclusion criteria for all healthy control participants:\n\n1. subjects with an active and serious medical disease\n2. subjects with an infectious disease\n3. consume any alcohol within 3 months before the study\n4. subjects with localized or systemic infection","70 Years",{"count":85,"type":21},196,"INTERVENTIONAL",[88],"PHASE2","The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.",[27],[92],"Child Class A or B","2026-03-26",{"date":95,"type":35},"2026-03-31",{"date":97,"type":35},"2020-10-22",{"date":99,"type":21},"2027-03-01",{"name":101,"class":42},"Indiana University",2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":86,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":43},"100582683","optimized-remission-in-alcohol-related-liver-cirrhosis-100582683","NCT06866496","Optimized Remission in Alcohol-related Liver Cirrhosis","Disease and Outcomes in Alcohol Related Liver Cirrhosis - A Prospective Cohort Study of Optimized Remission","Pro-ALC","Inclusion Criteria:\n\n* Clinical suspicion of cirrhosis related to use of alcohol, supported by biochemistry and ultrasound or other imaging techniques.\n* Informed written consent.\n\nExclusion Criteria:\n\n* The diagnosis of ALC is questioned with reasonable doubt.\n* Withdrawal of informed consent or no informed consent.",{"count":112,"type":21},350,[114],"NA","The incidence of liver cirrhosis is increased fivefold for men and tripled for women in the last forty years.\n\nThe clinical course of liver cirrhosis includes complications of ascites, hepatic encephalopathy, variceal bleeding, kidney dysfunction, and infections that markedly worsen prognosis. These complications are driven by the development of portal hypertension in the liver. This progression to the 'decompensated' stage is considered a hallmark in the disease course, as the decompensation is associated with a markedly increased risk of further complications and death.\n\nIncreasing evidence indicate that active measures of treatment of the underlying cause of liver disease and removal of the toxic agents causing cirrhosis may slow disease progression or even induce regression of cirrhosis. This concept is described as hepatic recompensation.\n\nThere is a need for clinical studies investigating novel biomarkers with the capability to predict and monitor improvement in alcohol related liver cirrhosis, Between 75% and 80% of patients with liver cirrhosis in Denmark have or have had a harmful use of alcohol.\n\nAlcohol related liver disease (ArLD) has a major impact on patients' health and lives, and there is an unmet need to investigate treatment options that not only relieves complications, but also address the underlying pathways of alcohol related liver disease, also in severe stages of alcohol related cirrhosis (ALC). Factors such as BMI, female gender and mild portal hypertension are known to be associated with an increased likelihood of recompensation. Additional factors of genetic activation and molecular biomarkers from the proteome and lipidome have only attracted minor attention, and the impact of treating the drivers of decompensation, portal hypertension and alcohol use, and their impact on the natural cause of disease, have not been addressed.\n\nThe molecular pathophysiology of ArLD is incompletely understood. Characterization of the proteome dynamics across the spectrum of ALD could provide new insights into disease mechanisms of both progression and remission of disease.\n\nSeveral markers of inflammation and cytokines are involved in driving decompensation and has the potential to predict the risk of early death. It is unknown whether such markers can predict remission and recompensation in ALC and AH. Prospective studies investigating the associations between biomarkers of metabolism and prognosis, monitoring and efficacy og treatment in ALC are missing.\n\nThe overall objective of the present study is to investigate the molecular profile and pathways in persons with ALD to support personalized monitoring and follow-up in liver cirrhosis.\n\nThe study is an incidence cohort in which patients will be followed from diagnosis to death or withdrawal from the cohort. We will seek to include patients consecutively within three months of diagnosis.\n\nAll patients with a debut of alcohol related liver cirrhosis during admission regardless of the reason for admission, are eligible for inclusion.\n\nAll participants in this study will be offered the standard of care treatment. Alcohol cessation intervention including medical treatment of withdrawal symptoms and craving, referral to municipal offers of alcohol treatment, and motivational interviews is part of the treatment.\n\nThe study will contribute to a better characterization of advanced liver disease related to alcohol and contribute to an improved future organization of treatment- and rehabilitation offers to patients with liver disease. thorough characterization and consecutive inclusion will enhance our understanding on the incidence, prevalence and impact of ALC in the population, as well as the utilization of health care resources allocated to its treatment.\n\nA deeper insight into the molecular mechanisms of liver progression and remission will, in combination with clinical data, support our ability to predict outcomes in cirrhosis, facilitate personalized monitoring aiming at providing the right treatment for the right patient at the right time.",[117,27],"Cirrhosis of the Liver",[119,120],"cirrhosis","ArLD","2025-03-05",{"date":123,"type":35},"2025-03-10",{"date":125,"type":35},"2024-12-22",{"date":127,"type":21},"2034-12-31",{"name":129,"class":42},"Copenhagen University Hospital, Hvidovre",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":86,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":151},"100446472","long-term-follow-up-of-patients-with-alcoholic-liver-cirrhosis-who-had-administered-cellgram-lc-in-pmc-p-07-study-100446472","NCT05093881","Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study","Inclusion Criteria:\n\n1. Those who participated in PMC-P-07 clinical trials and received Cellgram-LC\n2. Those who voluntarily agreed in writing to participate in this investigation\n\nExclusion Criteria:\n\n\\-",{"count":137,"type":21},100,[114],"This Long-term follow-up is designed to evaluate the safety of patient with Alcoholic Liver Cirrhosis who had administered Cellgram-LC in PMC-P-07 study.",[27],"2024-03-20",{"date":143,"type":35},"2024-03-21",{"date":145,"type":35},"2021-08-24",{"date":147,"type":21},"2028-03-31",{"name":149,"class":150},"Pharmicell Co., Ltd.","INDUSTRY",11,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":86,"phases":164,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":151},"100415401","phase-3-clinical-trial-to-evaluate-the-efficacy-and-safety-of-cellgram-lc-administration-in-patients-with-alcoholic-cirrhosis-100415401","NCT04689152","Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis","A Multicenter, Randomized, Open-label Phase III Clinical Trial to Evaluate Efficacy and Safety of the Cellgram-LC in Patients With Alcoholic Liver Cirrhosis","Cellgram-LC","Inclusion Criteria:\n\n1. At the time of screening, 19 or 70 years\n2. Patients diagnosed with alcoholic cirrhosis by combining alcohol history, imaging and pathological examination results, and clinical symptoms at screening, and belonging to Child-Pugh grade B or C (Child-Pugh score of 7 or more)\n3. Those whose survival period is more than 1 year when judged by the tester\n4. Those who can perform hepatic artery catheterization by inserting a catheter into the hepatic artery at the judgment of the examiner\n5. In the case of women of childbearing potential, a person who was confirmed negative in the pregnancy test at screening and agreed to use contraception\\* by the method permitted for this clinical trial during the clinical trial\n6. Those who can conduct clinical trials according to the clinical trial protocol\n7. A person who has consented in writing to voluntarily participate in this clinical trial\n\nExclusion Criteria:\n\n1. Those with a history of solid cancer including Hepatocellular Carcinoma (HCC) (within 5 years before screening), those who have been diagnosed with solid cancer and are currently undergoing chemotherapy or those whose hepatocellular carcinoma has been confirmed by screening tests\n2. Patients who underwent portal systemic shunting in the jugular vein\n3. Patients with alcohol consumption or hepatotoxic drugs within 6 months prior to screening\n4. Persons taking high-dose steroids, immunosuppressants, or antimicrobials due to severe infections for at least 1 month of screening\n5. Those who have major surgical operations, long-term biopsy, or significant trauma as judged by the investigator within 3 months before screening\n6. Those whose history of gastrointestinal bleeding is confirmed within 10 days of screening\n7. Those whose medical history or accompanying diseases following the screening time is confirmed\n\n   * If you have not been diagnosed with a malignant blood disease (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy)\n   * Severe aplastic anemia\n   * Liver transplant history\n   * Liver diseases of other causes besides alcoholic cirrhosis: hepatitis B and C, autoimmune liver disease (primary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis, etc.), weak liver toxicity, non-alcoholic fatty liver disease , NAFLD), Wilson's disease, iron excess, alpha-1-antitrypsin deficiency, etc.)\n   * Extrahepatic biliary stenosis\n   * Active portal vein or hepatic vein thrombosis\n   * Heart failure or respiratory failure\n   * Severe renal impairment (when the result of serum creatinine test exceeds 1.5 times the upper limit of normal)\n   * Acute or chronic infection requiring systemic treatment\n   * Severe coagulation disorder (if the tester judges it as a severe coagulation disorder or one of the following 1 to 3; 1. bleeding predisposition, 2. coagulation, 3. platelet≤50,000\u002Fmm3 and INR≥1.5)\n8. serologic test result (HIV, HAV, HBV, HCV, Syphilis infection) positive factor\n9. Patients unable to collect bone marrow due to bone marrow disease\n10. Those with a history of gentamicin hypersensitivity reaction\n11. Pregnant or lactating women\n12. Those with substance abuse experience within 1 year before screening\n13. Those who participated in other clinical trials within one month before screening and administered (or applied) clinical trial drugs (or medical devices)\n14. Those who previously participated in clinical trials related to cell therapy\n15. Patients judged to be inappropriate to participate in this clinical trial due to complications, etc., when judged by the investigator before screening or registration","20 Years","71 Years",{"count":163,"type":21},200,[165],"PHASE3","This phase III clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected hepatic artery.",[27],{"date":143,"type":35},{"date":170,"type":35},"2021-03-02",{"date":172,"type":21},"2028-01-02",{"name":149,"class":150}]