Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• adults aged 18-80 years

• at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection

• intubation and start of mechanical ventilation. This needs to start immediately after the event described in the inclusion criteria (b). For cases of head trauma this is defined as start in the ambulance or the emergency department

• likelihood that the duration of mechanical ventilation would be at least six days

• written informed consent provided by the patient or legal representative

Locations
Other Locations
Belgium
Hospital Erasme
RECRUITING
Brussels
Italy
Regional General Hospital F. Miulli
RECRUITING
Acquaviva Delle Fonti
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
Intensive Care Unit, Policlinico di Bari
RECRUITING
Bari
Ospedale Di Venere
RECRUITING
Bari
AUSL Bologna Ospedale Bellaria
RECRUITING
Parma
Azienda Ospedaliero Universitaria di Parma
RECRUITING
Parma
Azienda Ospedaliera di Perugia
RECRUITING
Perugia
Azienda ospedaliera Santa Maria di Terni
RECRUITING
Terni
Contact Information
Primary
Alberto Corriero, MD
alberto.corriero@gmail.com
+393280072443
Backup
Filomena Puntillo, MD, PhD
filomena.puntillo@uniba.it
+390805594237
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 186
Treatments
Experimental: Interventional: Probiotics
Patients will receive a four probiotic preparation (LactoLevure, UniPharma, Athens, Greece).) in capsules containing: Lactobacillus acidophilus LA-5 \[1.75 × 109 colony-forming units (cfu)\], Lactobacillus plantarum (0.5 × 109 cfu), Bifidobacterium lactis BB12 (1.75 × 109 cfu) and Saccharomyces boulardii (1.5 × 109 cfu).
Placebo_comparator: Control: Placebo
Patients will receive a placebo in capsules containing powdered glucose polymer.
Related Therapeutic Areas
Sponsors
Collaborators: Uni-Pharma
Leads: University of Bari

This content was sourced from clinicaltrials.gov