---
title: "OM-85 bacterial lysate for primary prevention of preschool wheezing: randomized placebo-controlled"
id: "pubmed-42705251"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42705251"
content_type: "clinical_feed_article"
specialty: "Pediatrics"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42705251/"
doi: "10.1016/S0140-6736(26)01443-1"
published_at: "2026-09-19T00:00:00.000Z"
evidence_level: "Clinical Trial, Phase II"
license: "CC-BY-NC-4.0 / Informational Use"
---
# OM-85 bacterial lysate for primary prevention of preschool wheezing: randomized placebo-controlled
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42705251
- **Specialty:** [Pediatrics](https://medichelpline.com/clinical-feed/pediatrics.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42705251/)
- **DOI:** [10.1016/S0140-6736(26)01443-1](https://doi.org/10.1016%2FS0140-6736(26)01443-1)
- **Published At:** 2026-09-19T00:00:00.000Z
- **Evidence Rating:** Clinical Trial, Phase II
## Executive GIST (TL;DR)
- Study published in Lancet reports a clinical trial evaluating the bacterial lysate **OM-85** for primary prevention of wheezing lower respiratory illness in **preschool children**. - Trial is described as a **randomised, placebo-controlled** clinical trial. - Article metadata lists multiple pediatric, pulmonology, allergy, and biostatistics investigators and US-based institutions involved. - Publication details include Lancet, 2026 Sep 19; volume 408, pages 1103–1113, DOI 10.1016/S0140-6736(26)01443-1, Epub 2026 Sep 7; PubMed PMID 42705251. - The manuscript is indexed as a Clinical Trial and is available as a free article. - The PubMed entry provides authorship and affiliations but the abstract text, numerical results, outcome measures, sample size, randomisation method, follow-up duration, statistical findings, safety data, and specific recommendations are not included in the provided source text. - Because the source excerpt contains mainly bibliographic and navigation content, key trial details (eligibility criteria, dosing regimen, primary and secondary endpoints, effect estimates, adverse events, and conclusions) were not reported in the supplied material. - Users should consult the full Lancet article or PubMed full-text links for complete methods and results before using the trial for clinical decision-making or guideline updates. - The PubMed entry links to Elsevier/Lancet full-text options and gives contact information for the corresponding author, but substantive trial data are not present in the source provided here.
## Clinical Analysis & Structured Key Points
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Epub 2026 Sep 7. # Use of the bacterial lysate OM-85 for the primary prevention of wheezing lower respiratory illness in preschool children: a randomised, placebo-controlled trial [Wayne J Morgan](https://pubmed.ncbi.nlm.nih.gov/?term=Morgan+WJ&cauthor_id=42705251)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-1 "Asthma and Airway Disease Research Center and the Department of Pediatrics, College of Medicine, University of Arizona, Tucson, AZ, USA."), [David T Mauger](https://pubmed.ncbi.nlm.nih.gov/?term=Mauger+DT&cauthor_id=42705251)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-2 "Division of Statistics and Bioinformatics, Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA."), [Leonard B Bacharier](https://pubmed.ncbi.nlm.nih.gov/?term=Bacharier+LB&cauthor_id=42705251)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-3 "Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA."), [Cindy S Bauer](https://pubmed.ncbi.nlm.nih.gov/?term=Bauer+CS&cauthor_id=42705251)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-4 "Division of Allergy and Immunology, Phoenix Children's, Phoenix, AZ, USA."), [Stephanie D Davis](https://pubmed.ncbi.nlm.nih.gov/?term=Davis+SD&cauthor_id=42705251)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-5 "Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA."), [Anne M Fitzpatrick](https://pubmed.ncbi.nlm.nih.gov/?term=Fitzpatrick+AM&cauthor_id=42705251)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-6 "Division of Pulmonology, Asthma, Cystic Fibrosis and Sleep \(PACS\), Emory University, Atlanta, GA, USA."), [Theresa W Guilbert](https://pubmed.ncbi.nlm.nih.gov/?term=Guilbert+TW&cauthor_id=42705251)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-7 "Department of Pediatrics, Cincinnati Children's Hospital and University of Cincinnati, Cincinnati, OH, USA."), [Daniel J Jackson](https://pubmed.ncbi.nlm.nih.gov/?term=Jackson+DJ&cauthor_id=42705251)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-8 "Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA."), [Meyer Kattan](https://pubmed.ncbi.nlm.nih.gov/?term=Kattan+M&cauthor_id=42705251)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-9 "Columbia University College of Physicians and Surgeons, New York, NY, USA."), [Dayna Long](https://pubmed.ncbi.nlm.nih.gov/?term=Long+D&cauthor_id=42705251)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-10 "Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA."), [Wanda Phipatanakul](https://pubmed.ncbi.nlm.nih.gov/?term=Phipatanakul+W&cauthor_id=42705251)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-11 "Division of Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA."), [S J Teach](https://pubmed.ncbi.nlm.nih.gov/?term=Teach+SJ&cauthor_id=42705251)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-12 "University of Vermont Larner College of Medicine, Burlington, VT, USA."), [Susan J Boehmer](https://pubmed.ncbi.nlm.nih.gov/?term=Boehmer+SJ&cauthor_id=42705251)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-2 "Division of Statistics and Bioinformatics, Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA."), [Aliva De](https://pubmed.ncbi.nlm.nih.gov/?term=De+A&cauthor_id=42705251)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-13 "Division of Pediatric Pulmonology, Department of Pediatrics, Columbia University Irving Medical Center/New York Presbyterian-Morgan Stanley Children's Hospital, New York, NY, USA."), [Ashley L Devonshire](https://pubmed.ncbi.nlm.nih.gov/?term=Devonshire+AL&cauthor_id=42705251)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-14 "Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, OH, USA."), [Jonathan M Gaffin](https://pubmed.ncbi.nlm.nih.gov/?term=Gaffin+JM&cauthor_id=42705251)[ 15 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-15 "Division of Pulmonary Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA."), [Michelle L Hernandez](https://pubmed.ncbi.nlm.nih.gov/?term=Hernandez+ML&cauthor_id=42705251)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-5 "Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA."), [Ian M Paul](https://pubmed.ncbi.nlm.nih.gov/?term=Paul+IM&cauthor_id=42705251)[ 16 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-16 "Department of Pediatrics, Pennsylvania State University College of Medicine, Hershey, PA, USA."), [William J Sheehan](https://pubmed.ncbi.nlm.nih.gov/?term=Sheehan+WJ&cauthor_id=42705251)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-17 "Children's National Hospital, Division of Allergy and Immunology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA."), [Jeffrey R Stokes](https://pubmed.ncbi.nlm.nih.gov/?term=Stokes+JR&cauthor_id=42705251)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-18 "Department of Pediatrics, Washington University, St. Louis, MO, USA."), [Fernando D Martinez](https://pubmed.ncbi.nlm.nih.gov/?term=Martinez+FD&cauthor_id=42705251)[ 19 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#full-view-affiliation-19 "Asthma and Airway Disease Research Center and the Department of Pediatrics, College of Medicine, University of Arizona, Tucson, AZ, USA. Electronic address: fdmartin@arizona.edu.") Affiliations Expand ### Affiliations * 1 Asthma and Airway Disease Research Center and the Department of Pediatrics, College of Medicine, University of Arizona, Tucson, AZ, USA. * 2 Division of Statistics and Bioinformatics, Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA. * 3 Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA. * 4 Division of Allergy and Immunology, Phoenix Children's, Phoenix, AZ, USA. * 5 Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. * 6 Division of Pulmonology, Asthma, Cystic Fibrosis and Sleep (PACS), Emory University, Atlanta, GA, USA. * 7 Department of Pediatrics, Cincinnati Children's Hospital and University of Cincinnati, Cincinnati, OH, USA. * 8 Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA. * 9 Columbia University College of Physicians and Surgeons, New York, NY, USA. * 10 Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA. * 11 Division of Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. * 12 University of Vermont Larner College of Medicine, Burlington, VT, USA. * 13 Division of Pediatric Pulmonology, Department of Pediatrics, Columbia University Irving Medical Center/New York Presbyterian-Morgan Stanley Children's Hospital, New York, NY, USA. * 14 Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, OH, USA. * 15 Division of Pulmonary Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. * 16 Department of Pediatrics, Pennsylvania State University College of Medicine, Hershey, PA, USA. * 17 Children's National Hospital, Division of Allergy and Immunology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA. * 18 Department of Pediatrics, Washington University, St. Louis, MO, USA. * 19 Asthma and Airway Disease Research Center and the Department of Pediatrics, College of Medicine, University of Arizona, Tucson, AZ, USA. Electronic address: fdmartin@arizona.edu. * PMID: **42705251** * DOI: [ 10.1016/S0140-6736(26)01443-1 ](https://doi.org/10.1016/s0140-6736\(26\)01443-1) Free article Item in Clipboard Clinical Trial # Use of the bacterial lysate OM-85 for the primary prevention of wheezing lower respiratory illness in preschool children: a randomised, placebo-controlled trial Wayne J Morgan et al. Lancet. 2026. Free article Show details Display options Display options Format Abstract PubMed PMID Lancet Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Lancet%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Lancet%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42705251/) . 2026 Sep 19;408(10560):1103-1113. doi: 10.1016/S0140-6736(26)01443-1. Epub 2026 Sep 7. ### Authors [Wayne J Morgan](https://pubmed.ncbi.nlm.nih.gov/?term=Morgan+WJ&cauthor_id=42705251)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-1 "Asthma and Airway Disease Research Center and the Department of Pediatrics, College of Medicine, University of Arizona, Tucson, AZ, USA."), [David T Mauger](https://pubmed.ncbi.nlm.nih.gov/?term=Mauger+DT&cauthor_id=42705251)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-2 "Division of Statistics and Bioinformatics, Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA."), [Leonard B Bacharier](https://pubmed.ncbi.nlm.nih.gov/?term=Bacharier+LB&cauthor_id=42705251)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-3 "Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA."), [Cindy S Bauer](https://pubmed.ncbi.nlm.nih.gov/?term=Bauer+CS&cauthor_id=42705251)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-4 "Division of Allergy and Immunology, Phoenix Children's, Phoenix, AZ, USA."), [Stephanie D Davis](https://pubmed.ncbi.nlm.nih.gov/?term=Davis+SD&cauthor_id=42705251)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-5 "Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA."), [Anne M Fitzpatrick](https://pubmed.ncbi.nlm.nih.gov/?term=Fitzpatrick+AM&cauthor_id=42705251)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-6 "Division of Pulmonology, Asthma, Cystic Fibrosis and Sleep \(PACS\), Emory University, Atlanta, GA, USA."), [Theresa W Guilbert](https://pubmed.ncbi.nlm.nih.gov/?term=Guilbert+TW&cauthor_id=42705251)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-7 "Department of Pediatrics, Cincinnati Children's Hospital and University of Cincinnati, Cincinnati, OH, USA."), [Daniel J Jackson](https://pubmed.ncbi.nlm.nih.gov/?term=Jackson+DJ&cauthor_id=42705251)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-8 "Department of Pediatrics, University of Wisconsin-Madison, Madison, WI, USA."), [Meyer Kattan](https://pubmed.ncbi.nlm.nih.gov/?term=Kattan+M&cauthor_id=42705251)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-9 "Columbia University College of Physicians and Surgeons, New York, NY, USA."), [Dayna Long](https://pubmed.ncbi.nlm.nih.gov/?term=Long+D&cauthor_id=42705251)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-10 "Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA."), [Wanda Phipatanakul](https://pubmed.ncbi.nlm.nih.gov/?term=Phipatanakul+W&cauthor_id=42705251)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-11 "Division of Immunology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA."), [S J Teach](https://pubmed.ncbi.nlm.nih.gov/?term=Teach+SJ&cauthor_id=42705251)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-12 "University of Vermont Larner College of Medicine, Burlington, VT, USA."), [Susan J Boehmer](https://pubmed.ncbi.nlm.nih.gov/?term=Boehmer+SJ&cauthor_id=42705251)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-2 "Division of Statistics and Bioinformatics, Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA."), [Aliva De](https://pubmed.ncbi.nlm.nih.gov/?term=De+A&cauthor_id=42705251)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-13 "Division of Pediatric Pulmonology, Department of Pediatrics, Columbia University Irving Medical Center/New York Presbyterian-Morgan Stanley Children's Hospital, New York, NY, USA."), [Ashley L Devonshire](https://pubmed.ncbi.nlm.nih.gov/?term=Devonshire+AL&cauthor_id=42705251)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42705251/#short-view-affiliation-14 "Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, OH, USA."), [Jonathan M Gaffin](https://pubmed.ncbi.nlm.nih.gov/?term=Gaff
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