The randomised CRL1505 trial reported a reduction in respiratory-infection burden, particularly in participants with recurrent episodes, without a significant difference in time to first infection.

To turn this result into a useful dossier, the documentary chain must remain continuous: strain deposit and identification, fermentation conditions, purity, viability or activity, stability, dose at the end of shelf life and delivery matrix.

The clinical section must preserve population, duration, comparator, primary and secondary endpoints, medicine use and statistical limitations. Only then can transferability to the product and permissible language be assessed.

The species name is not enough. If the strain, dose, process or format changes, the scientific question changes as well and new evidence on the marketed product may be required.

Why it matters

A strain-specific dossier reduces the risk of transferring a result obtained with one strain, dose and use condition to the probiotic category as a whole.

Evidence limit

Editorial application of the same RCT analysed on 30 July. It adds no new clinical findings and does not extend the effect to other strains or blends.

Editorial note. This content is intended for industry professionals. It does not constitute medical advice, therapeutic guidance or regulatory advice. Read our editorial method.

Read the original source · PMC / scientific article ↗