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Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
Sponsor: University of Bari
Summary
PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration. Multi-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.
Official title: Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2023-12-13
Completion Date
2026-07-15
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (9)
Hospital Erasme
Brussels, Belgium
Regional General Hospital F. Miulli
Acquaviva delle Fonti, BA, Italy
Intensive Care Unit, Policlinico di Bari
Bari, BA, Italy
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Di Venere
Bari, Italy
AUSL Bologna Ospedale Bellaria
Parma, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Azienda ospedaliera Santa Maria di Terni
Terni, Italy