Could probiotics stop ventilator pneumonia? new trial aims to find out
NCT ID NCT06092554
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests whether giving probiotics (LactoLevure) to ICU patients on ventilators can prevent ventilator-associated pneumonia. The trial will enroll 186 adults with head injury, stroke, or brain hemorrhage. Patients receive probiotic or placebo capsules twice daily for 30 days. The goal is to see if probiotics reduce infection rates and deaths.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Probiotics (LactoLevure)
- What this could lead to
- If it works, this could provide a simple, low-cost way to prevent lung infections in ICU patients on ventilators.
- What could go wrong
- This is a relatively small, early-stage trial. Probiotics may not reduce infection rates, and results may not apply to all ICU patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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213 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Sep 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 1. previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material \[mechanical or bioprosthetic cardiac valves\] 2. previous or current endocarditis 3. 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 4. tunnelled (not short-term) hemodialysis catheters 5. pacemakers or defibrillators Patients with peripherally inserted central catheters (PICCs), temporary central venous catheters, central venous dialysis catheters, coronary artery stents, coronary artery bypass grafts (CABG), or neurovascular coils are not excluded, nor are patients with mitral valve prolapse or bicuspid aortic valve if they do not meet any other exclusion criteria. * patients with sepsis and/or septic shock
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AUSL Bologna Ospedale Bellaria
Parma, Italy
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Azienda Ospedaliera di Perugia
Perugia, Italy
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Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
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Azienda Ospedaliero Universitaria di Parma
Parma, Italy
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Azienda ospedaliera Santa Maria di Terni
Terni, Italy
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Hospital Erasme
Brussels, Belgium
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Intensive Care Unit, Policlinico di Bari
Bari, BA, Italy
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Ospedale Di Venere
Bari, 70131, Italy
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Regional General Hospital F. Miulli
Acquaviva delle Fonti, BA, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Europe's ICUs join forces to take on a deadly lung infection
- Machine learning may forecast brain decline after head injury