Efficacy of Bacillus clausii in reducing duration of illness in acute diarrhoea in children 6-59 months of age admitted with severe dehydration

Abstract

Background: Acute infectious diarrhoea is the second commonest cause of under-five mortality in the world. It has been associated with an increased morbidity and high rate of admission into hospital due to severe dehydration. Multiple studies document that probiotics are effective in treating infectious diarrhoea in children. This study attempted to determine whether Bacillus.clausii (B.clausii) is effective in shortening acute diarrhoeal illness in under-five population with severe dehydration.
Methods: In a randomized, double-blind, placebo-controlled trial, children (age range: 6 months to 5 years) with acute diarrhoea and World Health Organization (WHO) criteria of severe dehydration were administered B.clausii, twice daily, for 5 days. Routine standard care and WHO protocols of managing diarrhea and dehydration were followed in both groups. Primary outcome measure was the duration of diarrhoea.
Results: In a per-protocol analysis of 90 children, the mean duration of diarrhoea in the B.clausii group (n=44) was insignificantly shorter (77.59 ± 34.10 hours) than the placebo group (n=46) (86.74 ± 40.16 hours) There was a mean difference between the groups of 9.15 hours (t (88) = 1.163, P = 0.248, 95% C.I -6.88 – 24.79). There was a significant decrease in the mean number of diarrhoeal motions on day 3 [B.clausii group 2.74±1.81 motions vs. Placebo group 3.80±2.70 motions; mean difference=1.05 motions; (t (88) = 2.169, P = 0.033, 95% C.I 0.09 – 2.02)].
Conclusion: In children admitted with acute diarrhea and severe dehydration, there was no significant difference in the duration of diarrhoea and duration of hospital stay in the two groups.