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<p>Probiotics have a long history as fermented food or food supplements. The health benefits and safety profiles of probiotics are strain-specific and should be evaluated individually. The aim of this study was to assess the safety of the <i>Lactobacillus plantarum GUANKE (GUANKE)</i> strain by conducting pharmacological studies, oral toxicity assessments, and investigating the colonization and translocation of <i>GUANKE</i> in experimental animal models. Three pharmacological studies were conducted to examine the effects of oral administration of <i>GUANKE</i> on gastric emptying, bile secretion, and gastric juice secretion. In an acute toxicity study, rats were orally administrated with different doses of <i>GUANKE</i> and monitored for 14 days. In the subacute toxicity study, both rats and beagles were administrated with varying doses of <i>GUANKE</i> for 28 consecutive days to evaluate hematologic, biochemical, and histological effects. The results showed that <i>GUANKE</i> administration did not result in any adverse effect on hematological parameters, biochemical parameters, urinary parameters, and organ indices. Importantly, no translocation of <i>GUANKE</i> to extra-intestinal organs or blood was observed following administration of the CFDA-SE labeled strain. In summary, this study demonstrated the safety of <i>GUANKE</i> intake<i>,</i> which encourages its potential application as a probiotic in clinical trials.</p>

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Preclinical Safety Assessment of the Oral Administration of Lactobacillus plantarum GUANKE in Animal Models

  • 期刊论文

  • 发表日期：

    2025年3月3日

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  • Yuewen Yang,
  • Yanlin Zhang,
  • Ruixiang Sun,
  • Wenjuan Du,
  • Yangyang Liu,
  • Lijun Zheng,
  • Zhihong Ren,
  • Ming ding Li,
  • Jianguo Xu

摘要

Probiotics have a long history as fermented food or food supplements. The health benefits and safety profiles of probiotics are strain-specific and should be evaluated individually. The aim of this study was to assess the safety of the Lactobacillus plantarum GUANKE (GUANKE) strain by conducting pharmacological studies, oral toxicity assessments, and investigating the colonization and translocation of GUANKE in experimental animal models. Three pharmacological studies were conducted to examine the effects of oral administration of GUANKE on gastric emptying, bile secretion, and gastric juice secretion. In an acute toxicity study, rats were orally administrated with different doses of GUANKE and monitored for 14 days. In the subacute toxicity study, both rats and beagles were administrated with varying doses of GUANKE for 28 consecutive days to evaluate hematologic, biochemical, and histological effects. The results showed that GUANKE administration did not result in any adverse effect on hematological parameters, biochemical parameters, urinary parameters, and organ indices. Importantly, no translocation of GUANKE to extra-intestinal organs or blood was observed following administration of the CFDA-SE labeled strain. In summary, this study demonstrated the safety of GUANKE intake, which encourages its potential application as a probiotic in clinical trials.