[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100291924":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":75,"studyPopulation":66,"armGroups":76,"interventions":87,"overallOfficials":66,"centralContacts":93,"locations":103,"responsibleParty":121,"collaborators":66,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":66,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":66,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":106,"whyStopped":66,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Medical University of Graz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Alpha diversity","16s rDNA sequencing of the stool microbiome","day 1",[14,17,20,22,26,28,29,32,34,36,38,40,43,45,47,49,51,53,55,57,60,63],{"measure":15,"description":16,"timeFrame":12},"Zonulin","ELISA",{"measure":18,"description":16,"timeFrame":19},"diamino-oxidase","day 1, day 7",{"measure":21,"description":16,"timeFrame":12},"Calprotectin",{"measure":23,"description":24,"timeFrame":25},"Gut permeability","marker panel","change between day 1 and day 7",{"measure":27,"description":11,"timeFrame":12},"taxonomic composition of the microbiome",{"measure":27,"description":11,"timeFrame":25},{"measure":30,"description":31,"timeFrame":12},"lipopolysaccharide","HEK blue cell assay",{"measure":33,"description":16,"timeFrame":12},"sCD14",{"measure":35,"description":16,"timeFrame":12},"lipopolysaccharide binding protein",{"measure":37,"description":31,"timeFrame":12},"bacterial DNA",{"measure":39,"description":24,"timeFrame":25},"bacterial translocation",{"measure":41,"description":42,"timeFrame":12},"cytokine panel","Bead array",{"measure":44,"description":16,"timeFrame":12},"carboxylated proteins",{"measure":46,"description":16,"timeFrame":12},"advanced oxidation end products",{"measure":48,"description":24,"timeFrame":25},"inflammation",{"measure":50,"description":16,"timeFrame":12},"myostatin",{"measure":52,"description":16,"timeFrame":12},"fibroblast growth factor 21",{"measure":54,"description":16,"timeFrame":12},"insulin like growth factor 1",{"measure":56,"description":16,"timeFrame":12},"Irisin",{"measure":58,"description":59,"timeFrame":12},"nutritional status","Questionnaire",{"measure":61,"description":62,"timeFrame":12},"Sarcopenia","MR\u002FCT scan",{"measure":64,"description":65,"timeFrame":12},"face portrait","face portraits \"selfies\" will be obtained and AI algorithms will be used to diagnose sarcopenia from selfies",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NON_RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":72,"maskingDescription":66,"whoMasked":73},"SINGLE",[74],"PARTICIPANT","Scientific background\n\nProtein-energy malnutrition (PEM) occurs in 65-90% of patients with chronic liver disease. PEM is caused by various factors including poor dietary intake, loss of appetite, decreased hepatic protein synthesis, malabsorption and hypermetabolism. It is associated with an increased risk of complications including ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome and mortality. There is a direct relation between the progression of the liver disease and the severity of malnutrition.\n\nMalnutrition and sarcopenia in liver cirrhosis patients\n\nPEM leads to sarcopenia as a common, but frequently overlooked, complication. Sarcopenia is defined as a decrease in muscle mass two standard deviations below the healthy young adult mean. Sarcopenia is associated with aging, chronic diseases and malignancy. To determine the severity of muscle wasting, computed tomography scan (CT) or magnetic resonance imaging (MRI) are an objective and reproducible technique. Sarcopenia negatively impacts on survival, correlates with the risk of infections, increases surgical risk and leads to a poor quality of life. Besides PEM also inflammation is of importance in the development of sarcopenia.\n\nDiversity in the microbiome in patients with liver cirrhosis and association with sarcopenia.\n\nThe gut microbiome of liver cirrhosis patients is altered compared to healthy individuals. Dysbiosis leads to an increased gut permeability, bacterial translocation and inflammation. This contributes to fibrogenesis and may also be related to hepatocarcinogenesis. Hence, new treatment approaches in cirrhosis focus on changing the microbial landscape.\n\nModulation the gut microbiome may also be a strategy to reverse sarcopenia by reducing systematic inflammation.\n\nHypothesis and aims\n\nThere is an association between gut microbiome composition, gut permeability and the existence of sarcopenia in cirrhotic patients.\n\nPrimary hypothesis: Diversity of the gut microbiome is reduced in liver cirrhosis patients with sarcopenia compared to those without sarcopenia or healthy controls.\n\nSecondary hypotheses: There is an association between gut microbiome composition, biomarker of gut permeability and bacterial translocation with the presence of sarcopenia in cirrhosis. Oral nutrition supplements (ONS) can influence the composition of the gut microbiome, gut permeability, bacterial translocation and inflammation. Sarcopenia can be diagnosed from patients portraits.\n\nAims: to investigate:\n\n* the composition of the gut microbiome\n* biomarkers of gut permeability, bacterial translocation and inflammation\n* the incidence and severity of sarcopenia\n* the impact of oral nutrition supplements (ONS) on the gut microbiome\n* whether artificial intelligence can be used to diagnose sarcopenia from face portraits.",[77,83],{"label":78,"type":79,"description":80,"interventionNames":81},"Cirrhosis + sarcopenia","EXPERIMENTAL","Patients with cirrhosis will receive 200ml of an oral nutritional supplement daily for 7 days.",[82],"Dietary Supplement: Fresubin energy",{"label":84,"type":85,"description":86,"interventionNames":66},"Control","NO_INTERVENTION","Patients with sarcopenia and no evidence of cirrhosis and healthy controls",[88],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":66},"DIETARY_SUPPLEMENT","Fresubin energy","dietary protein energy supplement",[78],[94,99],{"name":95,"role":96,"phone":97,"phoneExt":66,"email":98},"Vanessa Stadlbauer-Köllner, AssocProf Dr","CONTACT","+4331638582282","vanessa.stadlbauer@medunigraz.at",{"name":100,"role":96,"phone":101,"phoneExt":66,"email":102},"Julia Haberl, BSc","+4331638580777","julia.haberl@klinikum-graz.at",[104],{"facility":105,"status":106,"city":107,"state":66,"zip":66,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Medical University Graz","RECRUITING","Graz","Austria","AT",{"type":111,"coordinates":112},"Point",[113,114],15.44197,47.06733,{"lat":114,"lon":113},[117],{"name":118,"role":96,"phone":119,"phoneExt":120,"email":98},"Vanessa Stadlbauer-Köllner, MD","0043 316 385","82282",{"type":122,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100291924","microbiome-and-sarcopenia-in-patients-with-liver-cirrhosis-100291924",false,"NCT03080129","Microbiome and Sarcopenia in Patients With Liver Cirrhosis","Microbiome and Sarcopenia in Patients With Liver Cirrhosis: A Prospective Controlled Cohort Study","Inclusion Criteria:\n\n* Hospitalized patients for any reason with clinical\u002Fradiological\u002Fhistological diagnosis of cirrhosis\n* Age \\>18y\n* Informed consent\n* CT\u002FMRI scan within +\u002F-14 days of the baseline study visit\n\nExclusion Criteria:\n\n* Hepatic encephalopathy \\> grade 2 and or other cognitive disorder not allowing informed consent\n* advanced hepatocellular carcinoma\n* Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol",true,"ALL","18 Years","100 Years",{"count":135,"type":136},120,"ESTIMATED","INTERVENTIONAL",[139],"NA","Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity of malnutrition correlates with progression of liver disease and leads to sarcopenia in 30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased risk of complications and mortality.\n\nIn cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial translocation and inflammation. Since the microbiome is involved in nutrient uptake and metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A prospective controlled cohort study to investigate the interrelation of microbiome changes and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional interventions on the microbiome in cirrhosis will be studied. From this study information on how the gut microbiome composition and sarcopenia are associated in cirrhosis and if modulation of the gut microbiome by nutritional interventions is feasible will be collected.",[61,142],"Liver Cirrhosis",[144,61,145],"Liver cirrhosis","Microbiome","2026-10-07",{"date":148,"type":149},"2026-10-13","ACTUAL",{"date":151,"type":149},"2017-04-11",{"date":153,"type":136},"2030-12",{"name":5,"class":6},1]