Effectiveness and safety of bacillus clausii as an adjuvant therapy in paediatric patients with diarrhoea: a retrospective real-world evidence study

Background: Diarrhoeal disease remains one of the leading causes of morbidity and mortality among children under five, particularly in low- and middle-income countries. Bacillus clausii, a spore-forming probiotic, has gained attention for its stability and potential therapeutic role in gastrointestinal disorders. However, limited real-world data exist on its clinical use in pediatric populations in outpatient settings. Objective: To evaluate the effectiveness of Bacillus clausii as an adjuvant therapy in the management of diarrhoea among pediatric patients in routine clinical practice. Methods: This retrospective, multicenter, real-world evidence study analyzed anonymized medical records of 1374 pediatric patients diagnosed with diarrhoea and other related illness. Descriptive statistics were used to evaluate overall clinician-assessed pharmacotherapy response. Results: The majority of patients (71.54%) were aged 4 12 years, and 66.75% were male. Most patients (89.22%) were diagnosed with acute diarrhoea. By Day 7, 64.7% were deemed cured and 8.3% showed improvement. A notable reduction in diarrhoeal episodes was observed, with over 83% of patients who initially had >5 episodes/day reporting <2-3 episodes/day post-treatment. Stool consistency normalized in 89.88% of cases. No adverse events were reported. Conclusion: These real-world findings highlight the importance of early intervention and support the integration of Bacillus clausii into pediatric diarrhoea management protocols, while also underscoring the need for improved awareness, adherence to evidence-based treatment, and cautious case selection.