PE0301 safety and laboratory research

The 2025 paper assessed PE0301 in animal toxicology, analytical tests and laboratory assays. It did not assess health outcomes in humans.

Animal and laboratory study · 2025 · Fermentation (MDPI)

What was tested?

Relationship to the ingredient
Direct PE0301 research — the paper names PE0301 as the product code
Study design
Animal toxicology and laboratory study
Duration
14-day acute · 90-day subchronic

Reported findings

  • Animal study — acute toxicity:No mortality or pathological change in KM mice or SD rats after a single 20 g/kg body weight dose, followed for 14 days. LD50 reported as greater than 20 g/kg body weight.
  • Animal study — 90-day toxicity:In SD rats given 0.5, 1 or 3 g/kg body weight daily (n = 10 per group), no significant differences from control in body weight, food intake, organ weights, haematology, serum biochemistry, urinalysis or ophthalmology. The NOAEL is reported as 3 g/kg body weight, which was the highest dose tested.
  • Genotoxicity:No mutagenic activity in the Ames test up to 5000 µg per plate across five Salmonella strains with and without S9. In mice dosed at 2.5, 5 and 10 g/kg body weight, spermatocyte chromosome aberration rates were 0.2–0.4% against 0.2% in the negative control and 3.8% in the positive control; micronucleus rates did not differ from control.
  • Analytical:Nine biogenic amines, including histamine, tyramine, cadaverine and putrescine, were not detected by third-party analysis. The paper does not state a limit of detection.
  • Laboratory assay — pathogen inhibition:At 50 mg/mL in culture, inhibition was 100.0 ± 0.00% for P. gingivalis, 88.39 ± 8.89% for F. nucleatum subsp. polymorphum, 48.82 ± 9.85% for S. mutans and 18.74 ± 7.71% for A. actinomycetemcomitans. These are culture results, not measurements in an animal or a person.
  • Laboratory assay — H. pylori:Coaggregation with H. pylori reached 84.66 ± 1.37%, higher than the non-viable L. reuteri DSM17648 comparator at 66.47 ± 2.63%. Coaggregation is a binding measurement in a tube, not evidence of clearing an infection.
  • Laboratory assay — gastric epithelium:In AGS human gastric epithelial cells under 200 µM hydrogen peroxide, wound closure with the postbiotic powder was 46.79 ± 7.86% (p < 0.05). This is a scratch-closure assay in a cell line, not an ulcer model.

What the findings do not establish

The paper states its own limitations: all authors are employees of the Glac Biotech R&D division, there is no human clinical data, and batch-to-batch variability is possible. A single production lot was tested. The safety results come from rodents and the NOAEL equals the highest dose given, so no upper limit was established. Every antimicrobial and gastric result is from culture or a cell line — there is no infection model, no ulcer model and no human outcome. The published conclusion that the powder is suitable for infants and the elderly is an extrapolation from rodent toxicology, not a finding in those groups.

Extended study summary

Study summary: This paper reports the safety dossier for PE0301, the postbiotic powder fermented from AP-32, ET-66 and LPL28. Safety was assessed in rodents following OECD and Chinese national standard protocols: single-dose acute oral toxicity in KM mice and SD rats, a 90-day subchronic oral toxicity study in SD rats, an in-vivo mouse spermatocyte chromosome aberration test and an in-vivo mouse micronucleus test, alongside a bacterial reverse mutation (Ames) test and third-party biogenic amine analysis. Separately, and entirely in laboratory culture, the powder was tested for growth inhibition of oral and gastric pathobionts, for coaggregation with Helicobacter pylori, and for its effect on wound closure in AGS human gastric epithelial cells under hydrogen peroxide stress. The safety findings are animal and analytical data; the antimicrobial and gastric findings are in-vitro only. No human study was conducted.

Original publication

Safety Assessment and the Potential of a Postbiotic Powder Formulated from a Three-Strain Fermentation of Lactobacillus salivarius AP-32, Lactobacillus paracasei ET-66, and Lactobacillus plantarum LPL28

Li, C. M., Huang, Y. Y., Lin, C. H., Lin, J. H., Kuo, Y. W., Hsia, K. C., Tsai, S. Y., Huang, Y. F., Chen, C. W., Ho, H. H.

Fermentation (MDPI), 2025

Read the original paper: 10.3390/fermentation11110615

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