Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

NARecruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

July 15, 2026

Study Completion Date

July 15, 2026

Conditions
Ventilator Associated Pneumonia
Interventions
DIETARY_SUPPLEMENT

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.

OTHER

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.

Trial Locations (9)

70131

RECRUITING

Ospedale Di Venere, Bari

Unknown

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

All Listed Sponsors
collaborator

Uni-Pharma

INDUSTRY

lead

University of Bari

OTHER