The efficacy of saccharomyces boulardii in the treatment of acute watery diarrhea in children: a multicentre randomized controlled trial

Objective To assess the efficacy of saccharomyces boulardii in the treatment of uncomplicated, acute waterly diarrhea in children. Design: Randomized controlled trial. Place and Duration of Study: Carried out at three centres in Rawalpindi and Islamabad over a period of two months. Material and methods. Six months to 5 years old children, having acute watery diarrhea were included in the study and randomized into group A (treated with ORS and nutrition appropriate for age) and group B (treated with saccharomyces boulardii 250 mg b.d. orally, ORS and nutrition appropriate for age). They were followed up for six days. Frequency and consistency of stool along with duration of illness and tolerance of treatment, were recorded. These outcome measures from he test and the control group, were compared to find out the effects of treatment. Independent students t-test for continuous and Chi square test for categorical variables were applied to assess the statistical significance. Computer software package SPSS was used to process the data. Results: There were 50 children in control (A) and 51 in study (B) group. The mean age was 17.45 months (range 3 to 60 months). And 60% of the patients were males. The frequency of stools at day one was the same in the two groups (p=0.175)). However, at day 3 the frequency reduced significantly in group B as compared to that of group A(p=0.02). The consistency of stool showed positive trend in test group B as compared to control at day 3 (p=0.003) and day 6 (p=0.004) respectively. The average duration of the illness also decreased (p=0.006) by a mean of 1.1 days (95% Cl 1.4 to 0.24 days). The acceptance and tolerability of the drug were excellent and there were no reported side effects. Conclusion: Saccharomyces boulardii reduces the duration of mild to moderate watery diarrhea of acute onset in children. The consistency and frequency of stools also improved with treatment and the treatment was well-tolerated with no significant side effects. (author)