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Aim: To assess the efficacy and safety of Saccharomyces boulardii (S. boulardii) in acute watery diarrhoea and its role in reducing the frequency of episodes of diarrhoea in subsequent two months., Methods: Children from 2 mo to 12 years of age, with acute diarrhoea were selected according to inclusion criteria and randomised in S. boulardii group (treated with ORS, nutritional support and S. boulardii, 250 mg bid) and in control group (treated with ORS and nutritional support only). Active treatment phase was 5 d and each child was followed for two months afterwards. Frequency and consistency of stools as well as safety of drug was assessed on every visit. A comparison of two groups was done in terms of number of diarrhoeal episode in subsequent two months., Results: There were fifty patients in each group. Baseline characteristics such as mean age and the average frequency of stools were comparable in S. boulardii and control group at the time of inclusion in the trial. By d 3 it reduced to 2.7 and 4.2 stools per d respectively and by d 6 it reduced to 1.6 (S. boulardii Group) and 3.3 (control group). The duration of diarrhoea was 3.6 d in S. boulardii group whereas it was 4.8 d in control group (P = 0.001). In the following two months, S. boulardii group had a significantly lower frequency of 0.54 episodes as compared to 1.08 episodes in control group. The drug was well accepted and tolerated. There were no reports of the side effects during treatment period., Conclusion: S. boulardii significantly reduces the frequency and duration of acute diarrhoea. The consistency of stool also improves. The drug is well-tolerated.