37
Participants
Start Date
October 16, 2018
Primary Completion Date
December 31, 2021
Study Completion Date
December 31, 2021
Sanprobi Barrier-multispecies probiotic
"Multi-strain probiotic Sanprobi Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus lactis W19, Lactobacillus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24) or placebo. Patients will be randomized to one of the two products (A or B) each containing probiotic/placebo and administered for 12 weeks. After 12 weeks of supplementation, the probiotic/placebo product A or B will be discontinued and reintroduced again after next 4 weeks - patients will be switched to the other A or B group of probiotic/placebo arm. Patients will be administered with 4 capsules per day for 24 weeks (12 weeks for group A probiotic/placebo and 12 weeks for group B probiotic/placebo allowing 4 weeks washout between the group assignment)."
Placebo Comparator
Carrier material of Sanprobi Barrier-multispecies probiotic product, not containing bacterial strains,similar appearance as the probiotic
Department of Internal Diseases, Diabetology and Nephrology, Zabrze
Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland
UNKNOWN
Medical University of Silesia
OTHER