Bacillus clausii UBBC-07 reduces severity of diarrhoea in children under 5 years of age: a double blind placebo controlled study.

Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic (B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10th day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter (P<0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction (P<0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.