In vitro and in vivo toxicological safety assessment of indigenous probiotic Lacticaseibacillus rhamnosus NCDC 610.
- 2026-06
- Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 212
- PubMed: 41819674
- DOI: 10.1016/j.fct.2026.116060
Study Design
- Population
- C57BL/6 mice
- Methods
- A comprehensive preclinical safety assessment was performed in accordance with ICMR and OECD guidelines; a battery of in vitro and in vivo assays was conducted to evaluate virulence factors, mucin degradation, biogenic amine production, antibiotic susceptibility, cytotoxicity in HT-29 cells, and adhesion ability; acute and sub-acute oral toxicity studies were performed in C57BL/6 mice.
Lacticaseibacillus rhamnosus NCDC 610, isolated from the cereal-based fermented milk product Rabdi, has previously demonstrated antimicrobial, immunomodulatory, hypocholesterolemic, and antidiabetic properties. To ensure its safe application in foods and probiotic formulations, a comprehensive preclinical safety assessment was performed in accordance with ICMR and OECD guidelines. A battery of in vitro and in vivo assays was conducted to evaluate virulence factors, mucin degradation, biogenic amine production, antibiotic susceptibility, cytotoxicity in HT-29 cells, and adhesion ability. Additionally, acute and sub-acute oral toxicity studies were performed in C57BL/6 mice, including haematological, biochemical, histopathological, and immunological parameters. Lcb. rhamnosus NCDC 610 lacked virulence-associated attributes and did not exhibit haemolytic, gelatinase, coagulase, DNase, β-glucosidase, or β-glucuronidase activities. It neither utilized mucin nor produced biogenic amines, as confirmed by colourimetric and HPLC analyses. Further, Lcb. rhamnosus NCDC 610 was susceptible to clinically relevant antibiotics, maintained >95% cell viability in HT-29 cells, and showed moderate adhesion to intestinal epithelial cells. In vivo studies revealed no treatment-related toxicity, behavioural abnormalities, organ damage, bacterial translocation, or adverse immune responses. Collectively, these findings demonstrate the in vitro and in vivo safety of Lcb. rhamnosus NCDC 610 and support its potential for further evaluation as a functional probiotic candidate.
Research Insights
| Supplement | Dose | Health Outcome | Effect Type | Effect Size | Source |
|---|---|---|---|---|---|
| Lacticaseibacillus rhamnosus | — | Reduced Virulence-Associated Activity | Neutral | Large | View source"lacked virulence-associated attributes and did not exhibit haemolytic, gelatinase, coagulase, DNase, β-glucosidase, or β-glucuronidase activities" |
| Lacticaseibacillus rhamnosus | — | Safety And Tolerability | Neutral | Large | View source"no treatment-related toxicity, behavioural abnormalities, organ damage, bacterial translocation, or adverse immune responses" |