RecruitingNot ApplicableNCT06092554

Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

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

Sponsor

University of Bari

Enrollment

186 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Ventilator associated pneumonia

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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
likelihood that the duration of mechanical ventilation would be at least six days
written informed consent provided by the patient or legal representative

Exclusion Criteria20

has received mechanical ventilation more than 72 hours from start of screening
pregnancy or Lactation
patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes
HIV <200 CD4 cells/μL
those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2)
previous transplantation at any time
malignancy requiring chemotherapy in the last 3 months
neutropenia \[absolute neutrophil count < 500\])
patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded
ischemic bowel disease
oropharyngeal mucosal injury
inability to receive enteral medications
intent to withdraw advanced life support as per ICU doctor in charge
patients at risk of endovascular infection which includes
previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material \[mechanical or bioprosthetic cardiac valves\]
previous or current endocarditis
permanent endovascular devices (e.g., endovascular grafts \[e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids\] inferior vena cava filters, dialysis vascular grafts
tunnelled (not short-term) hemodialysis catheters
pacemakers or defibrillators
patients with sepsis and/or septic shock

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTLactoLevure

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.

OTHERPlacebo

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.