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Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a
Małgorzata Bartkowiak-Emeryk1, Andrzej Emeryk2, Jacek Roliński1
1Department of Clinical Immunology, Medical University of Lublin, Lublin, Poland.
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.
Insights
Polyvalent Mechanical Bacterial Lysate (PMBL®) impacts T cell populations in children with allergic asthma. This study shows PMBL® alters T cell subsets, suggesting potential immunological benefits for allergic respiratory conditions.
Area of Science:
- Immunology
- Allergology
- Pediatrics
Background:
- Polyvalent Mechanical Bacterial Lysate (PMBL®) contains bacterial antigens known to reduce respiratory infections.
- PMBL® has demonstrated immunological benefits in allergic patients by activating innate and specific immune responses.
- The precise immunologic mechanisms of PMBL® are not fully understood.
Purpose of the Study:
- To assess the effect of PMBL® on T cell populations in children diagnosed with allergic asthma.
- To investigate the immunomodulatory effects of PMBL® in pediatric allergic asthma patients.
Main Methods:
- A sub-study of the EOLIA trial included 49 children with allergic asthma and house dust mite allergy.
- Participants were divided into two groups: 21 receiving PMBL® and 28 receiving a placebo, both administered sublingually.
- T lymphocyte subsets (CD3+, CD4+, CD8+, Treg, NK-like T, NK cells) were analyzed at baseline and after 12 weeks.
Main Results:
- No significant baseline differences in blood cell counts were observed between groups, except for eosinophils.
- After 12 weeks of treatment, an increase in total T lymphocyte count was noted.
- Specific subsets like CD4+CD25+FOXP3+, CD8+, and NK-like T cells showed an increase, while CD69+ and CD25+ subsets of CD3+ decreased.
Conclusions:
- PMBL® administration over 3 months (10 days/month) significantly altered the T lymphocyte profile in children with allergic asthma.
- The study, part of the EOLIA clinical trial (NCT02541331), suggests PMBL® modulates T cell responses in allergic asthma.
- Further research is warranted to elucidate the full immunologic impact of PMBL®.
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