Trial reportJournal of translational medicine2019
A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections.
Trial report in Journal of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05063149 (Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
Who cites it
29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Impact of oral bacterial lysates on asthma control and immune parameters in children: evidence from an updated systematic review and meta-analysis of randomized trials.Frontiers in pharmacology · 2026Pooled it
- Vaccines for the common cold.The Cochrane database of systematic reviews · 2022Pooled it
- 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.International journal of clinical practice · 2021Pooled it
- Decentralized example of a randomized clinical trial: OM-85 use in older patients at risk of respiratory tract infections.Aging clinical and experimental research · 2026Trial
- Microbiota profiles in pre-school children with respiratory infections: Modifications induced by the oral bacterial lysate OM-85.Frontiers in cellular and infection microbiology · 2022Trial
- Prevalence and risk factors of recurrent respiratory tract infections in preschool children: a systematic review and meta-analysis.Jornal de pediatria · 2026Review
- 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
- Development of a Bacterial Lysate from Antibiotic-Resistant Pathogens Causing Hospital Infections.Microorganisms · 2025Article
- Article
- Oral Bacterial Lysate OM-85 Prevents Respiratory Tract Infections in Asthma: The OMRIA RWE Study.Journal of asthma and allergy · 2025Article
- Is There a Role for Immunostimulant Bacterial Lysates in the Management of Respiratory Tract Infection?Biomolecules · 2024Review
- Insights into the role of the respiratory tract microbiome in defense against bacterial pneumonia.Current opinion in microbiology · 2024Review
- Bacterial immunotherapy is highly effective in reducing recurrent upper respiratory tract infections in children: a prospective observational study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023Observational
- ERS International Congress 2022: highlights from the Paediatrics Assembly.ERJ open research · 2023Review
- Expert consensus on the role of OM-85 in the management of recurrent respiratory infections: A Delphi study.Human vaccines & immunotherapeutics · 2022Article
- Risk Factors Affecting Development and Persistence of Preschool Wheezing: Consensus Document of the Emilia-Romagna Asthma (ERA) Study Group.Journal of clinical medicine · 2022Article
- OM-85 Broncho-VaxomBiomedicines · 2021Article
- Prevention of recurrent respiratory infections : Inter-society Consensus.Italian journal of pediatrics · 2021Article
- Article
- Use of the Bacterial Lysate OM-85 in the Paediatric Population in Italy: A Retrospective Cohort Study.International journal of environmental research and public health · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOver many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children.
methodsThis study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom
resultsThe number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination.
conclusionsThe use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.
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Registered trials
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.