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Reviews on Recent Clinical Trials

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ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

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Research Article

Efficacy of OM-85 in Recurrent Respiratory Tract Infections

Author(s): Pietro Gareri*, Caterina Trevisan, Angela Marie Abbatecola, Alba Malara and Raffaele Antonelli Incalzi

Volume 18, Issue 3, 2023

Published on: 20 July, 2023

Page: [223 - 227] Pages: 5

DOI: 10.2174/1574887118666230518112806

Price: $65

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.

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[1]
Schaad UB, Esposito S, Razi CH. Diagnosis and Management of Recurrent Respiratory Tract Infections in Children: A practical guide. Arch Pediatr Infect Dis 2016; 4: e31039.
[2]
Bosch AATM, Biesbroek G, Trzcinski K, Sanders EAM, Bogaert D. Viral and bacterial interactions in the upper respiratory tract. PLoS Pathog 2013; 9(1): e1003057.
[http://dx.doi.org/10.1371/journal.ppat.1003057] [PMID: 23326226]
[3]
Forum of International Respiratory Societies. The Global Impact of Respiratory Disease - Second Edition. Sheffield European Respiratory society. Available From: www.who.int/gard/publications/The_Global_Impact_of_Respiratory_Disease.pdf (accessed 3 February 2019).
[4]
Feleszko W. Ruszczyński M, Zalewski BM. Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. Paediatr Respir Rev 2014; 15(2): 200-6.
[PMID: 24275566]
[5]
Wybran J, Libin M, Schandene L. Activation on natural killer cells and cytokine production in man by bacterial extracts. Immunopharmac Immunotoxicol 1989; 11(1): 17-32.
[http://dx.doi.org/10.3109/08923978909082140]
[6]
Emmerich B, Emslander HP, Pachmann K, Hallek M, Milatovic D, Busch R. Local immunity in patients with chronic bronchitis and the effects of a bacterial extract, Broncho-Vaxom, on T lymphocytes, macrophages, gamma-interferon and secretory immunoglobulin A in bronchoalveolar lavage fluid and other variables. Respiration 1990; 57(2): 90-9.
[http://dx.doi.org/10.1159/000195827] [PMID: 2122507]
[7]
Lusuardi M, Capelli A, Carli S, Spada EL, Spinazzi A, Donner CF. Local airways immune modifications induced by oral bacterial extracts in chronic bronchitis. Chest 1993; 103(6): 1783-91.
[http://dx.doi.org/10.1378/chest.103.6.1783] [PMID: 8404101]
[8]
Jurkiewicz D, Zielnik-Jurkiewicz B. Bacterial lysates in the prevention of respiratory tract infections. Otolaryngol Pol 2018; 72(5): 1-8.
[http://dx.doi.org/10.5604/01.3001.0012.7216] [PMID: 30460909]
[9]
Triantafillou V, Workman AD, Patel NN, et al. Broncho‐Vaxom® (OM‐85 BV) soluble components stimulate sinonasal innate immunity. Int Forum Allergy Rhinol 2019; 9(4): 370-7.
[http://dx.doi.org/10.1002/alr.22276] [PMID: 30615298]
[10]
Suárez N, Ferrara F, Rial A, Dee V, Chabalgoity JA. Bacterial lysates as immunotherapies for respiratory infections: Methods of preparation. Front Bioeng Biotechnol 2020; 8(8): 545.
[http://dx.doi.org/10.3389/fbioe.2020.00545] [PMID: 32582669]
[11]
Cazzola M, Capuano A, Rogliani P, Matera MG. Bacterial lysates as a potentially effective approach in preventing acute exacerbation of COPD. Curr Opin Pharmacol 2012; 12(3): 300-8.
[http://dx.doi.org/10.1016/j.coph.2012.01.019] [PMID: 22365728]
[12]
Orcel B, Delclaux B, Baud M, Derenne JP. Oral immunization with bacterial extracts for protection against acute bronchitis in elderly institutionalized patients with chronic bronchitis. Eur Respir J 1994; 7(3): 446-52.
[http://dx.doi.org/10.1183/09031936.94.07030446] [PMID: 8013600]
[13]
Trevisan C, Del Signore S, Fumagalli S, et al. Assessing the impact of COVID-19 on the health of geriatric patients: The European GeroCovid Observational Study. Eur J Intern Med 2021; 87: 29-35.
[http://dx.doi.org/10.1016/j.ejim.2021.01.017] [PMID: 33573885]
[14]
Abbatecola AM, Antonelli-Incalzi R. COVID-19 Spiraling of Frailty in Older Italian Patients. J Nutr Health Aging 2020; 24(5): 453-5.
[http://dx.doi.org/10.1007/s12603-020-1357-9] [PMID: 32346677]
[15]
Abbatecola AM, Antonelli Incalzi R, Malara A, et al. Disentangling the impact of COVID-19 infection on clinical outcomes and preventive strategies in older persons: An Italian perspective. J Gerontol Geriatr 2021; 70(1)
[http://dx.doi.org/10.36150/2499-6564-N440]
[16]
Gareri P, Fumagalli S, Malara A, et al. Management of older outpatients during the Covid19 pandemic: The GeroCovid Ambulatory Study. Gerontology 2021; 28: 1-6.
[http://dx.doi.org/10.1159/000516969] [PMID: 34182557]
[17]
Cao C, Wang J, Li Y, et al. Efficacy and safety of OM‐85 in paediatric recurrent respiratory tract infections which could have a possible protective effect on COVID‐19 pandemic: A meta‐analysis. Int J Clin Pract 2021; 75(5): e13981.
[http://dx.doi.org/10.1111/ijcp.13981] [PMID: 33405321]
[18]
Rossi GA, Esposito S, Feleszko W, et al. Immunomodulation therapy-clinical relevance of bacterial lysates OM-85. European respirat. Pulm Diseases 2019; 5(1): 17-23.
[http://dx.doi.org/10.17925/ERPD.2019.5.1.17]
[19]
Gao J, Gao X, Kong L. To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: Study protocol for a randomized controlled trial. Trials 2014; 15(1): 150.
[http://dx.doi.org/10.1186/1745-6215-15-150] [PMID: 24773830]
[20]
Standardised medical dictionary for regulatory activities (MedDRA) queries. Available From: www.meddra.org/ [Accessed on: Feb 3, 2019].

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