Clinical Trial

OM 85 to Prevent Respiratory Infections in Older At Risk Patients

Study acronym: OM85OLDER
Recruiting Phase 4
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Record status
This record was last updated March 18, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community. Products obtained from dead bacteria ("bacterial lysate") can be used to boost immune system and may reduce the risk of respiratory infections. Very little information is available on the effect of these substances in older people. This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes. The study will include a treatment arm, in which participants will received the lysate, and a control arm in which participants will received a matching placebo (i.e., a pill that has the same appearance of the lysate but does not contain the lysate itself).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-22.
Status change: Not Yet Recruiting → Recruiting 2025-03-14
Trial Details
NCT Number NCT06655272
Lead Sponsor Campus Bio-Medico University
Collaborators: OM Pharma SA
Conditions Respiratory Tract Infections (RTI)
Enrollment 360 participants
Start Date 2025-02-01
Primary Completion 2026-01 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-03-18