Randomised controlled clinical trial of Lactobacillus sporogenes (Bacillus coagulans), used as probiotic in clinical practice, on acute watery diarrhoea in children

To assess the clinical efficacy of Lactobacillus sporogenes (Bacillus coagulans), as probiotic preparation, against dehydrating diarrhoea in children. Methods Double-blind, randomised, placebo-controlled, hospital-based clinical trial with children aged 6-24 months who had diarrhoea with some dehydration. Children received tablets of L. sporogenes (B. coagulans) or placebo (control group) and oral rehydration salt solution for correction of initial dehydration as well as maintenance therapy. Duration, frequency, volume of diarrhoea and intake of ORS of two groups were compared as outcome variables. Results One hundred and forty-eight children participated, of whom 78 (Study group) received L. sporogenes (B. coagulans) and 70 received placebo (Control group). Differences in recovery rate (P = 0.2), duration (P = 0.5), frequency (P = 0.05), volume (P = 0.1) of diarrhoea, intake of ORS (P = 0.2) and other fluids (P = 0.1) were not significant between both groups. Neither did a subgroup analysis of children who had rotavirus as sole enteropathogens show any significant differences in duration (P = 0.5), frequency (P = 0.6), volume (P = 0.8) of diarrhoea, intake of ORS (P = 0.8) and other fluids (P = 0.8) among both groups. Conclusion L. sporogenes (B. coagulans), as an adjunct to ORS, had no therapeutic impact on management of acute dehydrating diarrhoea of diverse etiology including rotavirus associated diarrhoea in children.