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.

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. The 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. The 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: Does 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. Participants will: Take 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

NCT Number	NCT07025980
Lead Sponsor	Eva Cubric Collaborators: General Hospital Šibenik, Croatia, General Hospital Zadar, University Hospital Dubrava, University Hospital Rijeka, Clinical Hospital Merkur, University Hospital Sestre Milosrdnice, University Hospital of Split
Conditions	MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Diabetes Mellitus, Hypertension, Hyperlipidaemia
Enrollment	114 participants
Start Date	2025-07-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-18