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OM 85 to Prevent Respiratory Infections in Older At Risk Patients

NCT07178002 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-09-17

No results posted yet for this study

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).

Conditions

  • Respiratory Tract Infections (RTI)

Interventions

DRUG

Bacterial Lysate

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

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • OM Pharma SA

    collaborator INDUSTRY

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-01-31
Completion
2026-04-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178002 on ClinicalTrials.gov