114
Participants
Start Date
July 1, 2025
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2029
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.
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.
General Hospital Sibenik-Knin County, Šibenik
Lead Sponsor
General Hospital Šibenik, Croatia
OTHER
General Hospital Zadar
OTHER
University Hospital Dubrava
OTHER
University Hospital Rijeka
OTHER
Clinical Hospital Merkur
OTHER
University Hospital Sestre Milosrdnice
OTHER
University Hospital of Split
OTHER
Eva Cubric
OTHER