Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

NACompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Diabetes Mellitus, Type 2Metformin Adverse Reaction
Interventions
DIETARY_SUPPLEMENT

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)."

OTHER

Placebo Comparator

Carrier material of Sanprobi Barrier-multispecies probiotic product, not containing bacterial strains,similar appearance as the probiotic

Trial Locations (1)

41-800

Department of Internal Diseases, Diabetology and Nephrology, Zabrze

All Listed Sponsors
collaborator

Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland

UNKNOWN

lead

Medical University of Silesia

OTHER

NCT04089280 - Probiotics in Metformin Intolerant Patients With Type 2 Diabetes | Biotech Hunter | Biotech Hunter