186
Participants
Start Date
December 13, 2023
Primary Completion Date
July 15, 2026
Study Completion Date
July 15, 2026
LactoLevure
Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The probiotic capsules look identical to the placebo capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.
Placebo
Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The placebo capsules contain a powdered glucose polymer that is unharmful for the patient and will be provided by the sponsor. The placebo capsules look identical to the probiotic capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.
RECRUITING
Ospedale Di Venere, Bari
RECRUITING
Hospital Erasme, Brussels
RECRUITING
Regional General Hospital F. Miulli, Acquaviva delle Fonti
RECRUITING
Intensive Care Unit, Policlinico di Bari, Bari
RECRUITING
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo, Alessandria
RECRUITING
AUSL Bologna Ospedale Bellaria, Parma
RECRUITING
Azienda Ospedaliero Universitaria di Parma, Parma
RECRUITING
Azienda Ospedaliera di Perugia, Perugia
RECRUITING
Azienda ospedaliera Santa Maria di Terni, Terni
Uni-Pharma
INDUSTRY
University of Bari
OTHER