Saccharomyces boulardii plus azithromycin is superior to azithromycin alone in reducing the duration of diarrhea in children with acute colitis: a double-blind randomized placebo-controlled trial

Introduction: Diarrheal disorders remain a major disease burden throughout the world in pediatrics that remains a health problem. Several treatment methods have been proposed to treat diarrhea, however each of them has some problems. Objectives: The aim of this study was the evaluation the effect of oral Saccharomyces boulardii on the duration and severity of colitis. Patients and Methods: This randomized clinical trial study included ninety-four patients with acute colitis were enrolled. The children were divided randomly into case and control groups. The control group received supportive treatment including intravenous or oral fluid therapy (ORS solution), antibiotic treatment with azithromycin suspension, and zinc sulfate syrup daily for five days. In addition to the mentioned treatments, the intervention group received S. boulardii as a probiotic capsule. Then, the duration and severity of diarrhea based on the Vesikari score were evaluated for all the patients for five first days. Results: The mean of Vesikari score after the first day in both groups was similar, while after the third and fifth day in the probiotic group this score was lower than the control group (5.11 ± 1.73 versus 6.13 ± 2.25, P=0.031 and 2.36 ± 1.16 versus 4.28 ±1.19, P<0.001, respectively). Furthermore, the number of diarrhea per day in the probiotic group was significantly lower after the first day in contrast to the control group, which remains significant at the end of the fifth day (2.32 ± 0.51 versus 2.83 ± 1.23, P=0.047). Moreover, we found that the diarrhea duration (P<0.001), fever duration (P=0.029), and duration of hospitalization (P=0.006) were statistically lower in the case group as compared to the control. Conclusion: Saccharomyces boulardii had a beneficial effect as a probiotic agent in reducing the severity and duration of diarrhea, which could be beneficial for the treatment of colitis. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20161026030525N2); https://www.irct.ir/trial/24229; ethical code: IR.AJUMS.REC.1395.54.