Safety and immune-regulating effects of Limosilactobacillus reuteri LR08: Preclinical and clinical evidence from a randomized controlled trial.

Genomic analysis confirmed the absence of pathogenicity-related, antibiotic resistance, or biogenic amine synthesis genes in L. reuteri LR08.

• Whole-genome sequencing and bioinformatics analyses were conducted to assess the presence of genes related to pathogenicity, antibiotic resistance, and biogenic amine synthesis.
• No pathogenicity-related genes were identified in the genome.
• No antibiotic resistance genes were detected.
• No biogenic amine synthesis genes were found.

In vitro and animal studies confirmed that L. reuteri LR08 is non-hemolytic, non-cytotoxic, and demonstrates overall biosafety.

• In vitro assays evaluated hemolytic activity and cytotoxicity.
• Animal studies were conducted to assess overall biosafety.
• Results demonstrated non-hemolytic and non-cytotoxic characteristics.

LR08 supplementation significantly reduced serum uric acid levels compared with baseline.

• The reduction in serum uric acid was statistically significant (p < 0.001).
• The trial included 48 healthy adults who received either LR08 (30 billion CFU/day) or placebo for 8 weeks.
• The study was a randomized, double-blind, placebo-controlled trial.
• Registered as NCT06875362 on ClinicalTrials.gov.

LR08 supplementation significantly reduced LDL-C levels compared with baseline.

• The reduction in LDL-C was statistically significant (p = 0.007).
• Participants received 30 billion CFU/day of LR08 for 8 weeks.
• The comparison was made against baseline values within the LR08 group.

Compared with placebo, LR08 supplementation significantly increased salivary IgA, IgM, and calprotectin levels.

• Salivary IgA increased significantly (p = 0.039) compared with placebo.
• Salivary IgM increased significantly (p = 0.029) compared with placebo.
• Salivary calprotectin levels increased significantly (p < 0.05) compared with placebo.
• These immune parameters were measured over 8 weeks of supplementation in 48 healthy adults.

Gut microbiota analysis revealed increased α-diversity and enrichment of beneficial genera following LR08 supplementation.

• 16S rRNA sequencing was used to assess gut microbiota changes.
• α-diversity increased following LR08 supplementation.
• Beneficial genera including Blautia and Romboutsia were enriched.
• Pathways related to carbohydrate metabolism and genetic information processing were upregulated.