Trial reportPloS one2017
Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- 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
- Nasal carriage of Staphylococcus aureus in children with grass pollen-induced allergic rhinitis and the effect of polyvalent mechanical bacterial lysate immunostimulation on carriage status: A randomized controlled trial.Immunity, inflammation and disease · 2022Trial
- Clinical Effect of Bacterial Suspension in Patients with Moderate-to-Severe Allergic Conjunctivitis.Journal of clinical medicine · 2026Article
- Probiotics, Prebiotics, Synbiotics, Postbiotics, and Bioactive Agents in Modulating Harmful Oral Biofilms.Probiotics and antimicrobial proteins · 2026Review
- Gut-microbiota-mediated host immune modulation: mechanisms, pathological dysbiosis, and therapeutic frontiers.Frontiers in cellular and infection microbiology · 2026Review
- The Microecological-Immune Axis in Pediatric Allergic Diseases: Imbalance Mechanisms and Regulatory Interventions.Nutrients · 2025Review
- Prevention of IgE-Mediated Food Allergy: Emerging Strategies Through Maternal and Neonatal Interventions.The journal of allergy and clinical immunology. In practice · 2024Review
- Advances in Bacterial Lysate Immunotherapy for Infectious Diseases and Cancer.Journal of immunology research · 2024Review
- Oral Bacterial Lysate OM-85: Advances in Pharmacology and Therapeutics.Drug design, development and therapy · 2024Review
- Postbiotics: Current Trends in Food and Pharmaceutical Industry.Foods (Basel, Switzerland) · 2022Review
- From Skin Barrier Dysfunction to Systemic Impact of Atopic Dermatitis: Implications for a Precision Approach in Dermocosmetics and Medicine.Journal of personalized medicine · 2022Review
- Perspectives for the Use of Bacterial Lysates for the Treatment of Allergic Rhinitis: A Systematic Review.Journal of asthma and allergy · 2022Review
- Promising Immunomodulatory Effects of Bacterial Lysates in Allergic Diseases.Frontiers in immunology · 2022Review
- Term Infant Formulas Influencing Gut Microbiota: An Overview.Nutrients · 2021Review
- The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics.Nature reviews. Gastroenterology & hepatology · 2021Review
- Atopic Dermatitis as a Multifactorial Skin Disorder. Can the Analysis of Pathophysiological Targets Represent the Winning Therapeutic Strategy?Pharmaceuticals (Basel, Switzerland) · 2020Review
- Postbiotics-A Step Beyond Pre- and Probiotics.Nutrients · 2020Review
- [The efficacy of OM85-BV in the treatment of recurrent upper respiratory tract infection with adenoid hypertrophy and the preliminary exploration of potential therapeutic mechanism].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2020Article
- The airway inflammation induced by nasal inoculation of PM2.5 and the treatment of bacterial lysates in rats.Scientific reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnvironmental factors play a major role on atopic dermatitis (AD) which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend.
objectiveThis study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®), in the treatment of established AD in children.
methodsChildren aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF) during the study period, evaluated by Hazard Ratio (HR) derived from conditional Cox proportional hazard regression models accounting for repeated events.
resultsAmong the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85%) patients in the OM-85 group and 72 (88%) in the placebo group). Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI): 0.67-0.96), also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98). No major side effect was reported, with comparable and good tolerability for OM-85 and placebo.
conclusionsResults show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.
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Registered trials
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