The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

October 20, 2025

Study Completion Date

October 20, 2025

Conditions
IBS - Irritable Bowel SyndromeObesity
Interventions
DIETARY_SUPPLEMENT

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),

OTHER

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)."

Trial Locations (2)

51000

Clinical Hospital Centre, Rijeka

University Hospital Rijeka, Rijeka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Institute AllergoSan

UNKNOWN

lead

University Hospital Rijeka

OTHER