Verdict No. 542 · Search date 2026-07-18 · Methodology v0.6
OM-85 bacterial lysate, marketed as Broncho-Vaxom,
does it really help with Prevention of recurrent respiratory infections in children and high-risk groups?
30-Second Summary
B
Evidence Grade B · 68 · Safety caution
The pediatric recurrent-infection signal does not support broad generalization across ages, diseases, or lysate products.
What the
research showsIt may reduce the number of respiratory infections over a season in children prone to recurrent infections. Study quality and geographic heterogeneity are substantial, and the same benefit cannot be confidently generalized to adults or people with COPD.
research showsIt may reduce the number of respiratory infections over a season in children prone to recurrent infections. Study quality and geographic heterogeneity are substantial, and the same benefit cannot be confidently generalized to adults or people with COPD.
What the
ads claimBroad claims of general immune enhancement or prevention of colds at every age exceed the evidence. Results from a standardized OM-85 product cannot automatically be transferred to other bacterial lysates.
ads claimBroad claims of general immune enhancement or prevention of colds at every age exceed the evidence. Results from a standardized OM-85 product cannot automatically be transferred to other bacterial lysates.
Useful facts when choosing a product
- Prescription Broncho-Vaxom products are distributed in South Korea in 7 mg adult and 3.5 mg pediatric formulations.
- A common preventive regimen in trials and labeling is one fasting dose on ten consecutive days each month for three months, but the prescribed age-specific formulation should govern use.
- The evidence is concentrated on standardized OM-85 products and does not establish equivalence with other lysates or dietary supplements.
Gap Measurement · Verdict 542 · B 68
What the research actually shows
The most consistent signal concerns prevention over a limited period in children already prone to recurrent infection. Studies report fewer infections, less antibiotic use, and fewer missed days, but definitions and baseline risks differ.
Why this is classified as B (68)
Randomized evidence and a large meta-analysis of clinical infection counts justify a grade above C. Low GRADE certainty, heterogeneity, possible publication bias, and manufacturer and product concentration limit the verdict to B.
Counterpoint. A possible reduction in infection episodes does not show that OM-85 replaces vaccination, hygiene, treatment of underlying disease, or prevention of severe complications.
Rejudgment record. New verdict — Positive pediatric trials and meta-analyses balanced against heterogeneity, low quality, and manufacturer concentration
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Reduced infection frequency in children with recurrent respiratory infections | B | Multiple trials and meta-analyses are positive, but low quality, heterogeneity, and possible publication bias remain. |
| Prevention of respiratory exacerbations in high-risk adults or people with COPD | C | The immunostimulant class shows a small signal, but OM-85-specific findings and severe clinical outcomes are inconsistent. |
Cross-check — Codex and Claude
This verdict was drafted by Codex through literature review and source-existence checks, cross-checked through blind grading and adversarial audit, and settled by reapplying the methodology boundary rules. Cases with split grades were resolved through rejudgment.
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Yin et al. 2018 | Systematic review and meta-analysis of randomized trials in children with recurrent respiratory infections | 4,851 | Funding varied by study, with potential overall manufacturer concentration | Respiratory infection frequency, antibiotic use, and symptom duration | OM-85 reduced infection frequency by a mean of 2.33 episodes, but the authors rated certainty low and called for international multicenter trials. | Moderate-to-high weight for size, downgraded for heterogeneity and low quality |
| Del-Rio-Navarro et al. 2012 | Cochrane-style systematic review of immunostimulants for preventing respiratory infections in children | 4,060 | Individual trials included commercial funding; the review was independent | Incidence of acute respiratory infection | The pooled signal suggested about a 40% reduction, but trial quality was generally poor with substantial heterogeneity and possible publication bias. | Key synthesis defining both the favorable direction and the certainty limitations |
| Esposito et al. 2019 | Single-center phase IV double-blind randomized placebo-controlled trial | 288 | Conducted in a research setting with OM-85 product interests | At least one respiratory infection during follow-up | At least one infection occurred in 33% with OM-85 versus 65% with placebo. | Moderate weight for a direct pediatric outcome, limited by single-center and product concentration |
| Fraser and Poole 2022 | Cochrane systematic review of immunostimulants in adults with chronic bronchitis or COPD | 6,192 | Independent Cochrane review supported by NIHR | Exacerbations, antibiotic use, hospitalization, and quality of life | The class showed a small reduction in exacerbations and antibiotic use, while quality of life and hospitalization duration remained uncertain and the result was not specific to OM-85. | Supporting evidence that limits extrapolation to adults and COPD |
Receipt — 4 References
All 4 cited sources were verified for existence at the original page (as of 2026-07-18).
Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol. 2018;54:198-209. PMID: 29154122. DOI: 10.1016/j.intimp.2017.10.032.
checkedDel-Rio-Navarro BE, Espinosa-Rosales FJ, Flenady V, Sienra-Monge JJ. Immunostimulants for preventing respiratory tract infection in children. Evid Based Child Health. 2012;7(2):629-717. DOI: 10.1002/ebch.1833.
checkedEsposito S, Bianchini S, Bosis S, et al. 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. J Transl Med. 2019;17:284. PMID: 31443716. PMCID: PMC6708164. DOI: 10.1186/s12967-019-2040-y.
checkedFraser A, Poole P. Immunostimulants versus placebo for preventing exacerbations in adults with chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2022;11:CD013343. PMCID: PMC9661939. DOI: 10.1002/14651858.CD013343.pub2.
checkedDraft and rewrite: Codex (AI) · Verification: Codex blind grading and adversarial audit · Final adjudication: Claude
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-07-18 · Corrections: none
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-07-18 · Corrections: none
Cite this verdict
[Chamgap] Does OM-85 prevent recurrent respiratory infections in children? — Evidence Grade B·68. 4 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/om-85-recurrent-respiratory-infection-prevention/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.