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RECRUITING
NCT06092554
NA

Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

Sponsor: University of Bari

View on ClinicalTrials.gov

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

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.

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