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OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
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).
Key Details
Gender
All
Age Range
7 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2024-12-19
Completion Date
2026-04
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
Bacterial Lysate
Administration p.o. for 10 days per month for 3 months, two consecutive cycles.
Placebo
Matching placebo
Locations (1)
Fondazione Policlinico Universitario Campus Bio Medico
Roma, Italia, Italy