100
Participants
Start Date
November 10, 2021
Primary Completion Date
October 20, 2025
Study Completion Date
October 20, 2025
Probiotic mixture (OMNi-BiOTiC STRESS)
OMNi-BiOTiC STRESS containing 9 human bacterial strains \[Lactobacillus casei W56, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactobacillus plantarum W62, Bifidobacterium bifidum W23, with at least 7,5 billion CFU per one dose (3 g) and 15 billion CFU per two doses (6 g)\] and vitamin B (B2, B6, B12),
Placebo
"one powder portion bag self-administered orally twice a day for 8 weeks, identical in all aspects (organoleptic) as investigational product (IP) but containing excipient only.~* Powder portion bags are suitable for participants with intolerance to yeasts or lactose~* Each patient will receive a container with 112 powder portion bags (IP or placebo depending on the randomization) at the randomization period (0 weeks)."
Clinical Hospital Centre, Rijeka
University Hospital Rijeka, Rijeka
Collaborators (1)
Institute AllergoSan
UNKNOWN
University Hospital Rijeka
OTHER