Tests a sinbiotic supplement in adults with fatty liver disease
Tests a probiotic and fiber supplement against placebo in adults with metabolic fatty liver disease.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Šibenik, CroatiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07025980, who can take part
Where in Croatia
- General Hospital Sibenik-Knin CountyŠibenik, CroatiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eva Cubric
- Trial code
- NCT07025980
- Record updated
- 18 June 2025
- Original description
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.Read full original descriptionShow less
Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters 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
Inclusion: MASLD confirmed by ultrasound and elastography with CAP > 260 dB/m/MHz; other causes of chronic liver disease excluded and/or diagnosis confirmed by liver biopsy,; 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 > 130/85 mmHg determined during inclusion; treated diabetic or newly detected fasting serum glucose levels > 5.6 mmol/l; treated dyslipidemia or newly detected serum triglyceride levels > 1.7 mmol/L or HDL < 1.29 mmol/L for women/< 1.03 mmol/L for men),; signed informed consent.
Exclusion: 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),; 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,; severe psychiatric patients in whom cooperation and consent are questionable; pregnancy,; significant alcohol intake (>30g/day in men, >20g/day in women),; signs of liver cirrhosis or LSM>13 kPa measured TE,; inability to reliably measure CAP and LSM (IQR/median>30%),.