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ACTIVE NOT RECRUITING
NCT07178002
PHASE4

OM 85 to Prevent Respiratory Infections in Older At Risk Patients

Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

View on ClinicalTrials.gov

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

Interventions

DRUG

Bacterial Lysate

Administration p.o. for 10 days per month for 3 months, two consecutive cycles.

DRUG

Placebo

Matching placebo

Locations (1)

Fondazione Policlinico Universitario Campus Bio Medico

Roma, Italia, Italy