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Could probiotics stop ventilator pneumonia? new trial aims to find out

NCT ID NCT06092554

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

213 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 2026

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Brain Injuries, Traumatic intracerebral hemorrhage Pneumonia, Ventilator-Associated stroke disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AUSL Bologna Ospedale Bellaria

    Parma, Italy

  • Azienda Ospedaliera di Perugia

    Perugia, Italy

  • Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Italy

  • Azienda ospedaliera Santa Maria di Terni

    Terni, Italy

  • Hospital Erasme

    Brussels, Belgium

  • Intensive Care Unit, Policlinico di Bari

    Bari, BA, Italy

  • Ospedale Di Venere

    Bari, 70131, Italy

  • Regional General Hospital F. Miulli

    Acquaviva delle Fonti, BA, Italy

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Other studies related to the condition(s) this trial covers.