ArticleAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology2021
Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial.
Article in Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02541331 (Influence of Polyvalent Mechanical Bacterial Lysate ISMIGEN® on Clinical Course of Asthma and Related Immunological Parameters in Asthmatic Children), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Influence of Polyvalent Mechanical Bacterial Lysate ISMIGEN® on Clinical Course of Asthma and Related Immunological Parameters in Asthmatic Children (EOLIA Study): Randomised Double-blind Placebo-controlled Multicentre Parallel-group Study
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effects of probiotics, prebiotics, synbiotics and postbiotics on pediatric asthma: a systematic review.Frontiers in nutrition · 2025Pooled it
- Effect of immunostimulation with bacterial lysate on the clinical course of allergic rhinitis and the level of γδT, iNKT and cytotoxic T cells in children sensitized to grass pollen allergens: A randomized controlled trial.Frontiers in immunology · 2023Trial
- Clinical Effect of Bacterial Suspension in Patients with Moderate-to-Severe Allergic Conjunctivitis.Journal of clinical medicine · 2026Article
- Bacterial-Derived Immunomodulators as a Preventive Strategy for Viral Respiratory Tract Infections and Associated Wheezing or Asthma in Children: A Targeted Narrative Review.Children (Basel, Switzerland) · 2026Review
- Long-term Qipian® administration confers resistance to airway inflammation in OVA-induced asthmatic mice.Frontiers in allergy · 2026Article
- Gut microbiota in asthma: mechanisms, clinical evidence, and therapeutic opportunities.Frontiers in cellular and infection microbiology · 2026Review
- Is There a Role for Immunostimulant Bacterial Lysates in the Management of Respiratory Tract Infection?Biomolecules · 2024Review
- The Role of Postbiotics in Asthma Treatment.Microorganisms · 2024Review
- Article
- Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer.Journal of immunology research · 2024Review
- Microbiome and Asthma: Microbial Dysbiosis and the Origins, Phenotypes, Persistence, and Severity of Asthma.Nutrients · 2023Review
- 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.Journal of clinical medicine · 2022Article
- Promising Immunomodulatory Effects of Bacterial Lysates in Allergic Diseases.Frontiers in immunology · 2022Review
- Bacterial lysates in allergic rhinitis and chronic rhinosinusitis: Mechanisms and clinical evidence.Science progressReview
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
backgroundPolyvalent 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.
methodsThis 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.
resultsAt 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.
conclusionsThe 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.