Effect of Daily Bacillus subtilis DE111 Intake on GastrointestinalHealth and Respiratory Infections in Children Attending Day-care: ARandomised, Parallel, Double-blind, Placebo-controlled Study

Children beginning preschool typically have an increased prevalence of gastrointestinal and respiratory infections. This study aimed to evaluate safety and efficacy of the probiotic Bacillus subtilis DE111® in gastrointestinal health and respiratory infections in preschool children. In a randomised, parallel, double-blind placebo-controlled study 102 day-care attending children aged 2-6 years received B. subtilis DE111® (1 × 109 CFU) or placebo once a day for 8 weeks. Participant diaries were completed by parents and evaluated by investigators to follow the incidence and duration of indicators of gastrointestinal health and respiratory infections as well as any adverse events. Saliva samples were collected at baseline and completion of the intervention to measure sIgA levels. A significant reduction in duration of vomiting (2 days vs. 14 days, p=0.045), duration of hard stools (0 days vs 15 days, p=0.044), and duration of overall gastrointestinal discomfort (18 days vs. 48 days, p=0.0499) was seen. No difference in incidence of respiratory infection was observed (41.3% probiotic vs 36.2% placebo, p=0.60). A statistically significant increase of sIgA levels was observed in the placebo group (1.37-fold, p<0.01), but not in the probiotic group (1.05-fold, p=0.61). Overall, data suggests intake of the probiotic B. subtilis DE111® is safe for use in children and supports a healthy gastrointestinal tract with a reduced duration of vomiting, hard stools and overall gastrointestinal discomfort.