40
Participants
Start Date
February 20, 2024
Primary Completion Date
September 30, 2024
Study Completion Date
December 31, 2024
Probiotic
The experimental product is a dietary supplement manufactured by Cerbios-Pharma S.A, Each stick contains probiotic live cultures of Enterococcus lactis SF68® at a concentration of 10\^9 CFU, phytosterols, 6S-5MeTHF, maltose and silicon dioxide. Study participants will be given N°3 packs each containing 30 stick packs of 1.7 g each, in granulated form in sufficient quantity for the entire duration of the study (12 weeks). Subjects will be required to consume N°1 stick pack of the supplement daily after dinner for 12 continuous weeks. The product should be placed directly on the tongue and should be taken without water. After taking the product, the subject should drink half a glass of water to promote solubilization and transit. The supplement should be stored in a cool, dry place, away from light, moisture and direct heat sources to ensure the viability of the probiotic strain until the expiration date.
Placebo
N°1 stick/day of placebo food supplement (i.e., stick without added probiotics), with the same intake modalities as probiotic.
Careggi University Hospital, Florence
Azienda Ospedaliero-Universitaria Careggi
OTHER