A randomized controlled open labelled study to evaluate clinical efficacy of Bacillus clausii (TIL 19T, TIL 21C, TIL 28S, TIL 30R) in the management of acute diarrhoea in children

Abstract

Acute Diarrhoea in children is the most frequent gastroenterological disorder and is a common cause of dehydration in children. The management of acute diarrhoea consists of the replacement of lost fluid with glucose-electrolyte oral rehydration solution. Probiotics have been used as adjunctive therapy in the treatment of acute diarrhoea. In this study we evaluated the efficacy of Bacillus clausii (TIL 19T, TIL 21C, TIL 28S, TIL 30R) in management of Acute diarrhoea in children. 48 children aged between 6 months and 15 years with acute bacterial gastroenteritis or acute viral gastroenteritis were included in the study. The study group received poly antibiotic resistant B. clausii strains (TIL 19T, TIL 21C, TIL 28S, TIL 30R)as a probiotic along with standard treatment for diarrhoea and the control group received standard treatment for diarrhoea without B. clausii. The results at the end of 48 hours showed a significant improvement in very severe and high grade diarrhoea category in the children belonging to the study group. That is, all patients had recovered to low grade or normal grade (P < 0.01). Analysis of diarrhoeal stool group showed 64% of children in the control group continued to have loose stools as compared to just 24% in the study group (P < 0.01). No serious adverse events were recorded in both the groups. The use of B. clausii strains(TIL 19T, TIL 21C, TIL 28S, TIL 30R)in Acute Diarrhoea in children has shown to improve the recovery time from the illness and improvement in stool consistency due to its probiotic effect.