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

Abstract

Acute infectious diarrhoea is the second most common cause of under-five mortality in the world. It has also 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. The effectiveness of B. clausii, a probiotic, in shortening the duration of diarrhoeal illness in African children admitted with severe dehydration has not been examined. Aim To determine whether 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 WHO criteria of severe dehydration were administered B.clausii at 2x109CFUs/5ml vial or placebo, twice daily, for 5 days. Routine standard care and WHO protocols of managing diarrhea and dehydration were followed in both groups The primary outcome measure was the duration of diarrhoea. The secondary measures were the diarrhoeal stool output per day and the duration of stay in hospital. 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 ﾱ 34.10 hours) than the placebo group (n=46) (86.74 ﾱ 40.16 hours) There was a mean difference between the groups of9.15 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 2.74ﾱ1.81 motions vs. Placebo group 3.80ﾱ2.70 motions; mean difference=1.05 motions; (t (88) = 2.169, P = 0.033, 95% C.I 0.09 - 2.02)] and day 4 [B.clausii group 1.45ﾱ1.13 motions vs. Placebo group 2.35ﾱ 2.19 motions; mean difference = 0.893; (t (88) = 2.412, P = 0.018,95% C.I 0.157 - 1.629)]. There was no significant difference in the duration of stay in hospital between the groups [B. clausii group (4.14 ﾱ 0.93 days) vs. Placebo group (4.50 ﾱ 1.43days) There was a mean difference between the groups of 0.37 days (t (88) = 1.426, P = 0.157, 95% C.I -0.143 - 0.873). Conclusion In children admitted with acute diarrhea and severe dehydration, no significant difference in reducing the duration of diarrhoea and duration of hospital stay in the two groups. However significant decrease in the number of stools was seen on day 3 and 4 of treatment.