Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial

Abstract

Background Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate’s action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma. Methods This study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3−CD16+CD56+ were described. Results At baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3−CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased. Conclusions The EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes. Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.

Promising Immunomodulatory Effects of Bacterial Lysates in Allergic Diseases

“…IL-12 and IL-18 promoted by BLs stimulate NK1 polarization, which results in enhanced IFN-g secretion and IgE production suppression (88). The study by Bartkowiak-Emeryk et al showed an increase of NK cells in asthmatic children sublingually treated with PMBL (57). Moreover, DCs exposed to PCBL released increased levels of CCL2 and CCL3, chemokines important for chemoattraction of monocytes and NK cells (31).…”

“…However, as the data suggest, it can be assumed that the period in which the therapy is started is essential in the case of seasonal allergic diseases. For instance, the treatment plan in seasonal AR (SAR) usually consists of prescribing one PMBL tablet sublingually per day for 10 days with 20 days of a break for three consecutive months, and the treatment should preferably be started a few days before the beginning of the pollen season ( 57 ). In a perennial AR (PAR), the dosing regimen is the same as described above; however, it is assumed that in this group of patients, repeating this regimen twice per year may provide additional benefits ( 58 ).…”

“…The study by Bartkowiak-Emeryk et al. showed an increase of NK cells in asthmatic children sublingually treated with PMBL ( 57 ). Moreover, DCs exposed to PCBL released increased levels of CCL2 and CCL3, chemokines important for chemoattraction of monocytes and NK cells ( 31 ).…”

“…investigated the PMBL’s impact on the clinical course of AR in children. They showed that sublingual administration of the drug resulted in decreased eosinophil count in nasal smears ( 41 , 57 ). PCBL tested in adult patients and in murine models reduces eosinophil infiltration in nasal mucosa and lungs ( 11 , 97 ).…”

A Case-Control Study on the Changes in Natural Killer Cell Activity following Administration of Polyvalent Mechanical Bacterial Lysate in Korean Adults with Recurrent Respiratory Tract Infection

“…The absolute number of NK cells significantly increased by 56% in 28 COPD patients treated with PMBL [ 10 ]. A randomized controlled trial has shown an increase in NK cell count in 21 asthmatic children compared to the control group after PMBL treatment [ 27 ]. Our study showed a significant increase in IFN-γ levels in 301 patients treated with PMBL.…”