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.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2029

Conditions
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)Diabetes MellitusHypertensionHyperlipidaemia
Interventions
DIETARY_SUPPLEMENT

The test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS

The 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.

DIETARY_SUPPLEMENT

Placebo Drug

Contains 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.

Trial Locations (1)

22000

General Hospital Sibenik-Knin County, Šibenik

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

General Hospital Šibenik, Croatia

OTHER

collaborator

General Hospital Zadar

OTHER

collaborator

University Hospital Dubrava

OTHER

collaborator

University Hospital Rijeka

OTHER

collaborator

Clinical Hospital Merkur

OTHER

collaborator

University Hospital Sestre Milosrdnice

OTHER

collaborator

University Hospital of Split

OTHER

lead

Eva Cubric

OTHER