[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594940":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":69,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"General Hospital Šibenik, Croatia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"test group","EXPERIMENTAL","Test group (n 57) The test product is a ready-to-use preparation PROBalansHepatocare, manufactured by PharmaS d.o.o., which contains 8 strains of live cultures of microorganisms (Bifidobacteriumbreve BBR8, Bifidobacteriuminfantis SP37, Bifidobacteriumlongum SP54, Lactobacillus acidophilus LA1, Lactobacillus bulgaricus LB2, Lactobacillus paracasei IMC502®, Lactobacillus plantarum BG 112, Streptococcusthermophilus SP4) with about 100 billion bacteria (50x109 CFU\u002Fcapsule) in two capsules per day. In addition, the test product contains 100 mg of fructooligosaccharides, 210 mg of Ca-butyrate, and 10 ug (400 IU) of vitamin D in each capsule.",[13],"Dietary Supplement: The test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo group (n 57)The placebo is identical to the test product in all aspects (organoleptic), but contains only excipients (cellulose; hydroxypropyl-methyl cellulose) and 10 ug (400 IU) of vitamin D.",[19],"Dietary Supplement: Placebo Drug",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","The test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS","The test product is a ready-to-use preparation PROBalansHepatocare, manufactured by PharmaS d.o.o., which contains 8 strains of live cultures of microorganisms (Bifidobacteriumbreve BBR8, Bifidobacteriuminfantis SP37, Bifidobacteriumlongum SP54, Lactobacillus acidophilus LA1, Lactobacillus bulgaricus LB2, Lactobacillus paracasei IMC502®, Lactobacillus plantarum BG 112, Streptococcusthermophilus SP4) with about 100 billion bacteria (50x109 CFU\u002Fcapsule) in two capsules per day. In addition, the test product contains 100 mg of fructooligosaccharides, 210 mg of Ca-butyrate, and 10 ug (400 IU) of vitamin D in each capsule.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Drug","Contains only excipients (cellulose; hydroxypropyl-methyl cellulose) and 10 ug (400 IU) of vitamin D. They do not contain dyes, flavors or preservatives, and contain traces of soy and milk, the levels of which do not affect people who are lactose intolerant.",[15],[32],{"name":33,"affiliation":34,"role":35},"Marko Skelin, ass.prof.dr.sc, mag.pharm.","GH Sibenik-Knin County, Medical Faculty University of Rijeka, Croatia","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Eva Cubric, doctor of medicine","CONTACT","+38522641465","gastroenterologija@bolnica-sibenik.hr",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Marko Skelin, doctor of science, magh.pharm","+38522641641","marko.skelin@uniri.hr",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"General Hospital Sibenik-Knin County","Šibenik","Croatia","22000","HR",{"type":54,"coordinates":55},"Point",[56,57],15.8942,43.73429,{"lat":57,"lon":56},[60,61,63],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":62,"role":39,"phone":44,"phoneExt":26,"email":45},"Marko Skelin, PHD, mag.pharm",{"name":38,"role":64,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Eva Cubric","doctor medicine",[70,71,73,75,77,79,81],{"name":5,"class":6},{"name":72,"class":6},"General Hospital Zadar",{"name":74,"class":6},"University Hospital Dubrava",{"name":76,"class":6},"University Hospital Rijeka",{"name":78,"class":6},"Clinical Hospital Merkur",{"name":80,"class":6},"University Hospital Sestre Milosrdnice",{"name":82,"class":6},"University Hospital of Split","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":94,"type":95},114,"ESTIMATED","INTERVENTIONAL",[98],"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",[101,102,103,104],"MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)","Diabetes Mellitus","Hypertension","Hyperlipidaemia",[106],"elastography; human LRG1, liver enzymes, metabolic- dysfuncion steatotic liver disease, metabolic syndrome; probiotics, treatment","NOT_YET_RECRUITING","2025-06-10",{"date":110,"type":111},"2025-06-18","ACTUAL",{"date":113,"type":95},"2025-07-01",{"date":115,"type":95},"2029-07-31",{"name":67,"class":6},1]