Efficacy of OM-85 in Recurrent Respiratory Tract Infections

Pietro Gareri; Caterina Trevisan; Angela Marie Abbatecola; Alba Malara; Raffaele Antonelli Incalzi

doi:10.2174/1574887118666230518112806

Efficacy of OM-85 in Recurrent Respiratory Tract Infections

Rev Recent Clin Trials. 2023;18(3):223-227. doi: 10.2174/1574887118666230518112806.

Authors

Pietro Gareri¹, Caterina Trevisan^{2

3}, Angela Marie Abbatecola⁴, Alba Malara⁵, Raffaele Antonelli Incalzi⁶

Affiliations

¹ Center for Cognitive Disorders and Dementia, Catanzaro Lido, ASP Catanzaro, Italy.
² Geriatrics Division, Azienda Ospedale Università di Padova, Department of Medicine (DIMED), University of Padua, Italy.
³ Department of Medical Science, University of Ferrara, Ferrara, Italy.
⁴ Azienda Sanitaria Locale (ASL) Alzheimer's Disease Day Clinics, Frosinone, Italy.
⁵ ANASTE Humanitas Foundation, Rome Italy.
⁶ Unit of Geriatrics, Department of Medicine, Campus Bio-Medico University and Teaching Hospital, Rome, Italy.

PMID: 37202893
DOI: 10.2174/1574887118666230518112806

Abstract

Background: In older patients, prevention of acute respiratory tract infections (RTIs) is challenging. Experimental studies have consistently underlined an immune-potentiating effect of the bacterial lysates product OM85, on both cellular and humoral responses.

Objective: This work aimed to assess the potential efficacy of OM-85 for RTIs' prevention in older individuals.

Methods: This explorative longitudinal study included 24 patients aged 65 years or older recruited in the GeroCovid Observational Study- home and outpatient care cohort. For the study purposes, we included 8 patients treated with OM-85 from December 2020 to June 2021 (group A), and a control group of 16 patients, matched for sex and age, who did not receive bacterial lysates (group B). RTIs were recorded from the participants' medical documentation in an e-registry from March 2020 to December 2021.

Results: In 2020, group A experienced a total of 8 RTIs, which affected 6 out of 8 patients (75%); group B reported 21 RTIs, with at least one event in 11 out of 16 patients (68.7%). In 2021, RTIs affected 2 out of 8 patients (25%) in group A (p < 0.02), and 13 out of 16 patients (81.2%) in group B (within this group, 5 patients had two RTIs). The RTIs' cumulative incidence over the observation period significantly differed between groups (66.7% in group A vs. 24.3% in group B; p < 0.002), as well as the decrease in RTIs frequency from 2020 to 2021. No patients in group A were affected by COVID-19 during the observation period, while among controls, two patients had SARS-CoV-2 infection, notwithstanding three doses of vaccine.

Conclusion: This study suggests that bacterial lysates may provide clinical benefits for preventing RTIs. Additional research involving larger cohorts is required to verify the effectiveness of OM-85 in preventing RTIs in older adults.

Trial registration: ClinicalTrials.gov NCT04379440.

Keywords: COVID-19; OM-85; bacterial lysates; efficacy; older patients; respiratory tract infections.

Publication types

Observational Study

MeSH terms

Aged
COVID-19*
Humans
Longitudinal Studies
Research Design
Respiratory Tract Infections* / drug therapy
Respiratory Tract Infections* / prevention & control
SARS-CoV-2

Associated data

ClinicalTrials.gov/NCT04379440