Safety Assessment and Efficacy of Probiotic Bacillus clausii PBC429™ (MTCC 25459) for Management of Diarrhea

In this study, we have evaluated the in vivo safety in rats and the efficacy of the probiotic strain Bacillus clausii (shouchella clausi) PBC429™ in mice for the treatment of diarrhea. In the acute toxicity study, a single oral dose of 2000 mg/kg (500 × 10⁹ CFU/g) was administered to rats, followed by a sub-acute toxicity study for 28 days with repeated oral administration of Bacillus clausii PBC429™ at a dose of 250, 500, and 1000 mg/kg/day. In the present study, two doses of Bacillus clausii PBC429™ were tested in mice with castor oil-induced diarrhea. The results of this study indicate that no toxic effects of Bacillus clausii PBC429™ were observed at any dose administered for 28 days. No significant changes in body weight, clinical signs, hematological examinations, clinical biochemistry, gross pathology, or histopathology were observed between the control and test groups. Based on these results, NOAEL was found to be more than 2000 mg/kg and 1000 mg/kg (5 × 10¹¹ CFU), respectively. Bacillus clausii PBC429™ reduced the frequency of defecation, onset of diarrhea, total fecal weight, and percentage of defecation. Thus, the results of this study suggest that Bacillus clausii is safe for human consumption and is an effective antidiarrheal agent.