[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-disease-alcohol-related\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-disease-alcohol-related":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100481396","phase-1-intestinal-microbiota-transplant-in-alcohol-associated-liver-disease-100481396",false,"NCT05548452","Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease","Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","IMPACT","Inclusion Criteria:\n\n-\\>18 years of age\n\n* Advanced liver disease\n* Able to give written, informed consent\n* Alcohol as a cause of advanced liver disease\n* Continued sustained drinking\n* Having previously declined a referral to traditional AUD therapy services or having failed such treatments\n\nExclusion Criteria:\n\n* Lack of sustained drinking\n* Recent or current alcoholic hepatitis\n* Alcohol withdrawal symptoms\n* Clinically significant use of illicit drugs\n* Uncontrolled mood disorders or primary psychotic conditions\n* MELD score\\>17\n* Unclear diagnosis of chronic liver disease\n* Current hepatic encephalopathy on lactulose and\u002For rifaximin\n* WBC count\\\u003C1000\n* Non-elective hospitalization within last month\n* on dialysis\n* known untreated, in-situ luminal GI cancers\n* chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)\n* Dysphagia within 2 weeks\n* History of aspiration, gastroparesis, intestinal obstruction\n* Ongoing absorbable antibiotic use\n* Severe anaphylactic food allergy\n* allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior IMT\n* ASA Class IV or V\n* Pregnant or nursing patients\n* acute illness or fever on the day of planned FMT\n* Immunosuppression\n* Other conditions which make patients are poor candidate for this study per investigator judgement","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.",[28,29,30],"Liver Disease; Alcohol-Related","Cirrhosis","Alcohol Use Disorder",[32,30,29,33],"Intestinal Microbiota Transplant","Chronic Liver Disease","RECRUITING","2026-05-05",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2022-11-21",{"date":42,"type":21},"2026-12-30",{"name":44,"class":45},"Virginia Commonwealth University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100554029","alcohol-misuse-treatment-to-patients-newly-diagnosed-with-alcohol-related-liver-disease-a-randomized-controlled-trial-100554029","NCT06493773","Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Inclusion criteria\n\n* Age \\> 18 years\n* Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.\n* A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.\n* Excessive alcohol consumption defined as \\>7 units\u002Fweek for women and \\>14 units\u002Fweek for men within the previous year.\n* The patient is able to understand the purpose of the study and give informed oral and written consent to participate.\n\nExclusion criteria\n\n* Not enough proficiency in Danish to participate in interviews and questionnaires.\n* Pregnancy\n* Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.",{"count":54,"type":21},221,[56],"NA","To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.",[59,30,60,61,28],"Liver Diseases, Alcoholic","Treatment Adherence","Alcoholism",[63,64,65,66,67],"Alcoholic liver disease","Alcohol use disorder","Alcohol treatment","randomized clinical trial","hepatology clinic","2025-11-14",{"date":70,"type":38},"2025-11-18",{"date":72,"type":21},"2025-11-15",{"date":74,"type":21},"2029-04-01",{"name":76,"class":45},"Zealand University Hospital",1]