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Dead bacteria may protect elderly from lung infections

NCT ID NCT07178002

Prevention Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This study tests whether a pill made from dead bacteria (OM 85) can prevent lower respiratory tract infections in people aged 75+ living in nursing homes. Participants take the pill or a placebo for 10 days each month over 3 months. The goal is to see if the treatment reduces infections and related hospital visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bacterial lysate (OM 85)
What this could lead to
If it works, this could offer a simple way to reduce serious respiratory infections and hospitalizations in vulnerable older adults.
What could go wrong
This is a single Phase 4 trial with 360 participants. The effect may be small or not better than placebo, and results may not apply to all older adults.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

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

7 years and older

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: * Age 75 years or older * At least 2 RTIs in the year prior to enrollment * Patients must have been residing in nursing homes for at least 6 months and have an estimated length of stay in nursing homes of at least 6 months by their treating physician. * Signed informed consent. If participants are unable to provide informed consent due to cognitive impairment, consent will be provided by a legally recognized representative or trustee of the patient (pursuant to Article 4 of Law No. 219 of December 22, 2017). * Have a life expectancy of at least one year in the judgment of their treating physician. Exclusion Criteria: * Patients with known allergy or previous intolerance to any component (including the excipient) of the study drug * Patients with active neoplasia and prognosis of less than one year * Patients with previous organ transplantation * Patients treated with prohibited drugs (see Table 1) in the 3 months prior to the start of the study * Patients who have taken bacterial lysates in the 6 months prior to enrollment or are currently using them * Patients regularly treated with oral corticosteroids * Patients unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements) * Patients with any other clinical condition that, in the opinion of the investigator, would not allow completion of the protocol and safe administration of the study drugs

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder prevention target

As listed by the trial registrant

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

Respiratory tract infections (RTI)

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Campus Bio Medico

    Roma, Italia, 00128, Italy

More trials for these conditions

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