Prevention of Irinotecan Induced Diarrhea by Probiotics

PHASE3CompletedINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

August 31, 2022

Study Completion Date

November 30, 2022

Conditions
DiarrheaCancer
Interventions
DRUG

Probio-Tec® BG-VCap-6.5

Each capsule contents: 2 lyophilized probiotic strains, total amount of minimum 2,7x10 9 CFU/cps, ratio LGG®: BB-12® = 50% : 50% (Culture percentages are based on cell concentration and are approximate) Lactobacillus rhamnosus GG® (ATCC 53103) Bifidobacterium animalis subsp. lactis BB-12® (DSM 15954) Additives: maltodextrin, microcrystalline cellulose, silicium dioxide, magnesium stearate

DRUG

Placebo

Maltodextrin

Trial Locations (1)

833 10

National Cancer Institute, Bratislava

All Listed Sponsors
collaborator

National Cancer Institute, Slovakia

OTHER_GOV

lead

S&D Pharma SK s.r.o.

INDUSTRY

NCT02819960 - Prevention of Irinotecan Induced Diarrhea by Probiotics | Biotech Hunter | Biotech Hunter