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A randomized double-blind placebo-controlled study assessed the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in the outpatient management of acute watery diarrhea in children.
The study enrolled 180 participants aged between six months to five years with acute mild to moderate diarrhea and was randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo accompanied with oral rehydration salts and zinc supplementation.
The patients were followed up for three months for the recurrence of diarrhea.
The observations from the study were as follows-
- The mean duration of diarrhea in the probiotic group was 54.16 hours.
- The mean duration of diarrhea in the placebo group was 59.48 hours.
- The difference in the duration of diarrhea was 25.21 hours in those administered with probiotic or placebo within 24 hours of diarrhea onset.
- The difference in duration of diarrhea was 13.84 hours in those administered with probiotics within 48 hours of diarrhea onset.
- No significant differences in the stool frequencies were observed between the two arms.
- After three months, 15% in the probiotic group reported episodes of diarrhea.
- After three months, 18.5% in the placebo group reported episodes of diarrhea.
- The probiotic group demonstrated a considerably lower (31.02 hours) mean duration of diarrhea than the placebo group (48 hours).
Thus S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was found to be effective in reducing the duration of diarrhea on the administration within 48 hours of diarrhea onset. Furthermore, in the subsequent three months, it also reduced the recurrence of diarrhea and its intensity.
Source: Pediatr Gastroenterol Hepatol Nutr. 2021 Sep;24(5):423-431. doi: 10.5223/pghn.2021.24.5.423. Epub 2021 Sep 8. PMID: 34557395; PMCID: PMC8443851.