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
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.
pregnancy,
significant alcohol intake (>30g/day in men, >20g/day in women),
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,
signs of liver cirrhosis or LSM>13 kPa measured TE,
Parallel
The test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS
Dietary supplementThe 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/capsule) 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.
Placebo Drug
Dietary supplementContains 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.
change in the controlled attenuated coefficient CAP (dB/m/MHZ) for steatosis
change in liver stiffness measurement (LSM) (kPa) measured by transient elastography for fibrosis
(1st and 2nd measured on FibroScan device, manufacturer Echosens, Paris, France)
change in serum levels of aspartate aminotransferase AST (U/L), alanine transferase ALT (U/L), gamma-glutamyl transferase GGT (U/L), ferritin (ng/ml)
change in serum levels of glucose (mmol/l) and fasting insulin (pmol/L), calculation of insulin resistance using the Homeostatic Model Assessment for Insulin Resistance formula HOMA-IR (glucose (mmol/l) x insulin (pmol/L)/22.5)
change in serum levels of cholesterol (mmol/L), triglycerides (mmol/L), HDL-cholesterol (mmol/L) and LDL-cholesterol (mmol/L)
change in waist circumference (cm) and body mass index (BMI=body weight (kg)/body height2(m)), kg/m2)
Click on the lead sponsor to view all of their trials.
Eva Cubric
Lead sponsor
General Hospital Šibenik, Croatia
Sponsor institution
General Hospital Šibenik, Croatia
Collaborator
General Hospital Zadar
Collaborator
University Hospital Dubrava
Collaborator
University Hospital Rijeka
Collaborator
Clinical Hospital Merkur
Collaborator
University Hospital Sestre Milosrdnice
Collaborator
University Hospital of Split
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
