SynthesisWorld journal of pediatrics : WJP2010
OM-85 BV, an immunostimulant in pediatric recurrent respiratory tract infections: a systematic review.
Synthesis in World journal of pediatrics : WJP, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02148796 (Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness), which is not on this map. Cited by 50 papers, 4 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.
Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)
Who cites it
50 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Preclinical Evaluation of Bacterial Lysates in Murine Disease Models: A Systematic Review.Immunity, inflammation and disease · 2026Pooled it
- Bacterial lysate treatment in allergic disease: A systematic review and meta-analysis.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2021Pooled 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
- Immunostimulants for preventing respiratory tract infection in children.The Cochrane database of systematic reviews · 2006Pooled it
- OM-85 BV for primary prevention of recurrent airway infections: a pilot randomized, double-blind, placebo-controlled study.Einstein (Sao Paulo, Brazil) · 2020Trial
- 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.Journal of translational medicine · 2019Trial
- Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study.PloS one · 2017Trial
- Prevention of infection in immunosuppressive patients with autoimmune nephrosis by using an immunostimulating bacterial lysate Broncho-vaxom.Human vaccines & immunotherapeutics · 2012Trial
- 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
- A critical analysis of the effect of OM-85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta-analysis.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2024Article
- Diverging patterns in innate immunity against respiratory viruses during a lifetime: lessons from the young and the old.European respiratory review : an official journal of the European Respiratory Society · 2024Review
- Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer.Journal of immunology research · 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
- Association of low physical activity with higher respiratory tract infections frequency among pre-school children.Pediatric research · 2023Article
- 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
- The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions.The Journal of allergy and clinical immunology · 2022Review
- Can bacterial lysates be useful in prevention of viral respiratory infections in childhood? The results of experimental OM-85 studies.Frontiers in pediatrics · 2022Review
- Prevention of recurrent respiratory infections : Inter-society Consensus.Italian journal of pediatrics · 2021Article
- Acupoint Herbal Patching for Long-Term Immune Function in Children with Recurrent Respiratory-Tract Infections: A Systematic Review of Real-World Data.Medical acupuncture · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study was conducted to assess the efficacy of OM-85 BV (Broncho-Vaxom) in the prevention of pediatric recurrent respiratory tract infections (RTIs). Available evidence suggests that defining recurrent RTIs as >or=3 infections per fall-winter semester is both medically and epidemiologically justified. Therefore, this criterion was chosen as a primary endpoint.
methodsTrials were identified through consultation of bibliographic databases and other channels. Eleven non-blinded studies plus one dealing with primary prevention were excluded and eight randomized controlled trials were included in the meta-analysis. The data were compared at 6 months, which represented the end of most studies. The complete database was examined according to the guidelines of the Cochrane collaboration.
resultsThe mean age of children and the number of RTIs in the preceding year were comparable at admission. Of the patients in the OM-85 BV treated population (n=435), 32% had recurrent RTIs (that is, >or=3 RTIs/6 months) vs. 58.2% in the placebo treated population (n=416; P<0.001). Sensitivity analysis showed that this was not driven by any particular trial. The results of this review were also positive for the active treatment regarding the secondary variables, which were represented by the number of patients with at least one RTI and the mean number of RTIs.
conclusionsThis meta-analysis shows, as observed in several individual trials, that the population treated with OM-85 BV had significantly and consistently fewer cases of recurrent RTIs. The data suggest that the effect is greater in patients at increased risk of recurrent 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.