OM 85 to Prevent Respiratory Infections in Older At Risk Patients

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).

NCT Number	NCT07178002
Lead Sponsor	Fondazione Policlinico Universitario Campus Bio-Medico Collaborators: OM Pharma SA
Conditions	Respiratory Tract Infections (RTI)
Enrollment	360 participants
Start Date	2024-12-19
Primary Completion	2026-01 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2025-09-17