NCT07025980Not yet recruitingPhase 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.
Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters in Patients With Metabolic Associated Steatotic Liver Disease
Source: ClinicalTrials.gov · Last updated 18 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Eva Cubric
- NCT number
- NCT07025980
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 114
- From 1 Jul 2025 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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),
Other illness
- 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.
Other
- 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%),
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital Sibenik-Knin County Coordinator of this site? Confirm its status | Šibenik | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.