Actively Recruiting
Study of OM 85 Bacterial Lysate to Prevent Respiratory Infections in Nursing Home Residents Aged 75 and Older
Led by Campus Bio-Medico University · Updated on 2025-03-18
360
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Older adults living in nursing homes face a higher risk of respiratory infections compared to those living in the community. This research aims to evaluate if a bacterial lysate called OM 85 can reduce lower respiratory tract infections in this vulnerable population. The study focuses on people aged 75 and older who have experienced at least two respiratory tract infections in the previous year, addressing a gap in knowledge about the effects of OM 85 in elderly individuals with multiple health conditions. Participants will be randomly assigned to receive either the bacterial lysate OM 85 or a matching placebo. The lysate is given orally for 10 days each month over two cycles of three months each. The study will last for 12 months, during which researchers will compare the incidence of respiratory infections between the two groups. All participants will also receive recommended vaccines, ensuring consistent immunization across the study. Throughout the study, participants will be closely monitored for respiratory infections, hospital admissions, emergency room visits, and antibiotic use. Researchers will collect demographic, clinical, and functional data to understand factors linked to higher infection rates. Safety will be assessed by tracking any treatment-emergent adverse events. Participation involves regular evaluations over a year to gather comprehensive information on the effects of OM 85 in this older population.
CONDITIONS
Brief Title
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Research Team
S
Silvia Travaglini, MD
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