[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eva Cubric\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100594940","phase-2-effect-of-sinbiotic-with-multispecies-probiotics-on-liver-parameters-liver-enzymes-ultrasound-elastography-and-adipokines-in-same-cases-in-patients-with-metabolic-associated-steatotic-liver-disease-100594940",false,"NCT07025980","Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters Liver Enzymes, Ultrasound, Elastography and Adipokines in Same Cases) in Patients With Metabolic Associated Steatotic Liver Disease.","Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters in Patients With Metabolic Associated Steatotic Liver Disease","Inclusion Criteria:\n\n* MASLD confirmed by ultrasound and elastography with CAP \\> 260 dB\u002Fm\u002FMHz;\n* other causes of chronic liver disease excluded and\u002For diagnosis confirmed by liver biopsy,\n* presence of metabolic syndrome according to the definition of the International Diabetes Federation (IDF): waist circumference for women over 80 cm or over 94 cm for men, and at least two of the other criteria (treated hypertensive or blood pressure \\> 130\u002F85 mmHg determined during inclusion; treated diabetic or newly detected fasting serum glucose levels \\> 5.6 mmol\u002Fl; treated dyslipidemia or newly detected serum triglyceride levels \\> 1.7 mmol\u002FL or HDL \\\u003C 1.29 mmol\u002FL for women\u002F\\\u003C 1.03 mmol\u002FL for men),\n* signed informed consent.\n\nExclusion Criteria:\n\n* pregnancy,\n* significant alcohol intake (\\>30g\u002Fday in men, \\>20g\u002Fday in women),\n* presence of autoimmune, viral, cholestatic (primary biliary cholangitis, primary sclerosing cholangitis, obstructive biliary tree diseases) or metabolic (hemochromatosis, Wilson) causes of chronic liver disease, transplant patients, malignant diseases, free fluid in the abdomen, significant small bowel resections,\n* signs of liver cirrhosis or LSM\\>13 kPa measured TE,\n* use of medications that can promote the development of steatosis (e.g. corticosteroids, high doses of estrogen, methotrexate, amiodarone, valproate), and medications that can affect the composition of the microbiota for at least 3 months before the start of the study (antibiotics and probiotics),\n* inability to reliably measure CAP and LSM (IQR\u002Fmedian\\>30%),\n* severe psychiatric patients in whom cooperation and consent are questionable.","ALL","18 Years","75 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Scientific hypothesis: the use of a synbiotic preparation with a multi-strain probiotic in patients with MASLD can lead to a decrease in non-invasive elastographic parameters of hepatic steatosis and fibrosis and an improvement in liver function.\n\nThe main objective of this study is to examine whether the test product affects the improvement of liver function measured by elastographic parameters or at least the prevention of further disease progression.\n\nThe goal of this clinical trial is to learn if sinbiotics works to improve liver function in adult patients with MASLD The main questions it aims to answer are:\n\nDoes sinbiotic lowers elastographic parameters od steatosis and fibrosis? Does it change liver function by lowering liver enzymes, blood lipids and sugar? Can sinbiotics lower CV risks and improve quality of life? Researchers will compare sinbiotic to a placebo (a look-alike substance that contains no drug) to see if sinbiotic works in MASLD patients.\n\nParticipants will:\n\nTake sinbiotic or a placebo every day (td) for 9 months Visit the clinic once every 3 months for checkups, and at the begining and after 9 months for blood tests and US with elastography Keep a diary of their symptoms, diet, activity",[27,28,29,30],"MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)","Diabetes Mellitus","Hypertension","Hyperlipidaemia",[32],"elastography; human LRG1, liver enzymes, metabolic- dysfuncion steatotic liver disease, metabolic syndrome; probiotics, treatment","NOT_YET_RECRUITING","2025-06-10",{"date":36,"type":37},"2025-06-18","ACTUAL",{"date":39,"type":21},"2025-07-01",{"date":41,"type":21},"2029-07-31",{"name":43,"class":44},"Eva Cubric","OTHER",""]