[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-steatosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-steatosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,78],{"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":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100623725","impact-of-a-probiotic-supplementation-with-lifestyle-modification-on-liver-steatosis-fibrosis-and-metabolic-health-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-masld-100623725",false,"NCT07400367","Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Inclusion Criteria:\n\n* ALT ≥ 60 U\u002FL\n* Liver steatosis identified by ultrasound\n* Meet at least one cardiometabolic criteria:\n\n  1. BMI ≥ 25 kg\u002Fm2 (Asian ≥23)\n  2. Waist circumference: \\> 94cm (M) 80cm(F)\n  3. Fasting blood glucose ≥ 100 mg\u002FdL\n  4. HbA1c ≥ 5.7\n  5. Receiving treatment of diabetes\n  6. Receiving treatment of Hypertension\n  7. Average home blood pressure: ≥ 130\u002F85 mmHg\n  8. TG ≥ 150 mg\u002FdL\n  9. HDL ≤ 40 mg\u002FdL\n  10. Receiving treatment of dyslipidemia\n\nExclusion Criteria:\n\n* HBsAg(+)\n* Anti-HCV (+)\n* Cirrhosis\n* Excessive alcohol intake ( Male over 210g\u002Fwk; Female over 140mg\u002Fwk)\n* Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+))\n* Could not rule out drug related hepatitis\n* Receiving drug that might induce liver steatosis:\n* Glucocorticoids\n* Amiodarone\n* Tamoxifen\n* Methotrexate\n* Valproate\n* Tetracycline\n* Chemotherapeutic agents\n* Receiving immune modulators or biologics\n* Receiving antibiotics within 1 month\n* Receiving any cancer treatment\n* Have diagnosis of \"Catastrophic Illness\" defined by Health Administration of Taiwan\n* eGFR\\\u003C60\n* Pregnancy\n* Currently enrolled in other dietary or pharmacology clinical trial","ALL","18 Years","80 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It is defined as fatty liver confirmed by imaging or biopsy, accompanied by at least one cardiometabolic risk factor (e.g., hyperglycemia, dyslipidemia, hypertension, or obesity). Its pathological progression ranges from simple steatosis to steatohepatitis, primarily driven by excessive energy intake, hepatic lipid accumulation, and insulin resistance.\n\nMASLD is currently the most prevalent chronic liver disease globally, with a prevalence rate of approximately 30-40%. However, there is no satisfactory pharmacological treatment, leaving lifestyle modification as the primary therapeutic approach. Many patients struggle to effectively adjust their habits, leading to persistent hepatic inflammation and damage, which may eventually progress to end-stage diseases such as cirrhosis and hepatocellular carcinoma. In many developed countries, MASLD has become the leading indication for liver transplantation, imposing a heavy burden on healthcare systems.\n\nGut dysbiosis is closely linked to MASLD. An imbalance in the gut microbiota disrupts the gut-liver axis, leading to impaired intestinal mucosal barrier function. This allows bacterial components to enter the circulation, further triggering hepatic inflammation and abnormal lipid metabolism. Consequently, modulating the gut microbiota is considered a potential therapeutic strategy.\n\nOver the past decade, probiotics, prebiotics, and synbiotics have been extensively studied as non-pharmacological treatments for NAFLD. Multiple studies indicate that these products can reduce liver enzymes (AST, ALT), insulin resistance (HOMA-IR), and inflammatory markers (hs-CRP, TNF-α). The most effective combinations typically involve Lactobacillus, Bifidobacterium, and Streptococcus, with a recommended duration of approximately 12 weeks. However, the impact of these products on liver fibrosis, hepatic fat accumulation, and cardiometabolic risk factors remains inconclusive.\n\nThe probiotic product to be tested consists of Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, and Lactobacillus reuteri GL-104. This formulation complies with food safety regulations. In clinical studies, it had been proven as an effective adjuvant method that increased beneficial gut bacteria such as Akkermansia muciniphila and improved the control of blood glucose, lipids, and inflammatory markers.\n\nStudy Objectives\n\nThis study aims to investigate the efficacy of this probiotic product as an adjuvant therapy alongside lifestyle modifications in adult patients with MASLD. We will evaluate its impact on:\n\n1. The degree of liver fibrosis and steatosis\n2. Cardiometabolic risk factors (BMI, waist circumference, blood lipids, and blood glucose).\n3. Inflammatory markers.\n4. Gut microbiota composition.",[27,28,29,30,31],"Liver Elastography","Liver Steatosis","Liver Function Test","Insulin Resistance","Cardiometabolic Risk Factors",[33,34,35,36],"MASLD","Probiotics","Liver fibrosis","Liver steatosis","RECRUITING","2026-04-03",{"date":40,"type":41},"2026-04-06","ACTUAL",{"date":43,"type":41},"2026-04-01",{"date":45,"type":21},"2027-08",{"name":47,"class":48},"Fu Jen Catholic University Hospital","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100523997","endoscopic-ultrasound-shear-wave-for-liver-fibrosis-in-masld-patients-the-rumipamba-trial-100523997","NCT06102980","Endoscopic Ultrasound Shear Wave for Liver Fibrosis in MASLD Patients: The RUMIPAMBA Trial","Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography: The RUMIPAMBA Diagnostic Trial","Inclusion Criteria:\n\n* Patients referred for any kind of endoscopic procedure.\n* Without clinical suspicion of advanced liver fibrosis.\n* Acceptance to participate in the study.\n\nExclusion Criteria:\n\n* History of greater amounts of alcohol per week (140 g\u002Fweek and 210 g\u002Fweek for females and males respectively).\n* Significant or advanced fibrosis by Fibrosis-4 Index (FIB4) or the aspartate aminotransferase to platelet ratio index (APRI).\n* Any liver space-occupying lesion in the US.\n* Comorbidities or conditions related to avoidance of interventional procedures, namely: pregnancy or nursing, coagulopathy or any risk of bleeding, Anaesthesiology Society Association classification IV or higher, New York Heart Association functional class III or IV.","79 Years",{"count":59,"type":21},30,[24],"Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver fibrosis in patients with screening criteria of metabolic dysfunction-associated steatotic liver disease (MASLD), with absent-to-mild liver fibrosis. Similar research has been published but using vibration-controlled transient elastography (VCTE), recommended mainly due to its lower cost and less invasiveness. However, VCTE is limited to the anatomical proportions of the patient's body, and cannot assess the right hepatic lobe with less reliability, contrary to the EUS-SWE.",[28,63],"Fibrosis, Liver",[36,65,66,67,35],"Fatty liver","Endosonography","Elastography","2024-09-22",{"date":70,"type":41},"2024-09-24",{"date":72,"type":41},"2023-11-01",{"date":74,"type":21},"2025-04-01",{"name":76,"class":48},"Instituto Ecuatoriano de Enfermedades Digestivas",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100550425","acceptability-and-feasibility-of-a-new-approach-to-engage-patients-with-steatotic-liver-disease-in-physical-activity-100550425","NCT06446908","Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity","Inclusion Criteria:\n\n* \\>18 years of age,\n* confirmed MASLD or MASH without cirrhosis\n* access to a computer with an internet connection\n\nExclusion Criteria:\n\n* liver disease from another cause,\n* the existence of cirrhosis on imaging or clinically,\n* weekly alcohol consumption over 50g,\n* having a contraindication to PA without medical clearance (the Get Active questionnaire from the Canadian Society for Exercise Physiology is used to determine if medical clearance is needed),\n* being already enrolled in a supervised exercise intervention or PA behaviour change intervention or currently meeting PA guidelines of 150 mins\u002Fweek\n* the need for a wheelchair, cane, walker, or other support(s) to move",{"count":85,"type":21},12,[24],"Steatosis is the building of fat in the liver. Steatotic liver disease (SLD) regroups MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH. MASH is a leading cause of liver transplantation in Canada. There is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA).\n\nIs a counselling intervention to help patients progressively engage in more PA a feasible and acceptable approach? Objectives. This proposal has three primary objectives: 1) To assess the feasibility of our PA counselling intervention (to be delivered online) with SLD patients; 2) To evaluate the acceptability of our intervention; 3) To evaluate the feasibility of the study methods\u002Fprocedures.\n\nMethodology. This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.\n\nPA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.\n\nBased on past studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.\n\nThe primary outcomes of the project are to evaluate the feasibility and acceptability of the trial and intervention. The secondary outcomes are Daily PA time and biological\u002Fimaging data evolution",[28,89,33],"MASH",[91,92,93,94],"Physical activity","coaching","telehealth","liver","NOT_YET_RECRUITING","2024-05-31",{"date":98,"type":41},"2024-06-06",{"date":100,"type":21},"2024-08-01",{"date":102,"type":21},"2027-03-31",{"name":104,"class":48},"Hopital Montfort"]