Pediatric Gastroenterology, Hepatology & Nutrition

The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition (대한소아소화기영양학회)
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Effect of Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 on Acute Watery Diarrhea: A Randomized Double-Blind Placebo-Controlled Study in Indian Children

  • Ghosh, Apurba (Department of Pediatrics, Institute of Child Health) ;
  • Sundaram, Balasubramaniam (Department of Pediatrics, Kanchi Kamakoti Childs Trust Hospital) ;
  • Bhattacharya, Piyali (Department of Pediatrics, Sanjay Gandhi Post Graduate Institute of Medical Science) ;
  • Mohanty, Nimain (Department of Pediatrics, MGM Medical College) ;
  • Dheivamani, Nirmala (Department of Pediatric Gastroenterology, Institute of Child Health) ;
  • Mane, Sushant (Department of Pediatrics, Grant Govt. Medical College & Sir J.J. Group of Hospitals) ;
  • Acharyya, Bhaswati (Department of Pediatric Gastroenterology, Institute of Child Health) ;
  • Kamale, Vijay (Department of Pediatrics, MGM Medical College) ;
  • Poddar, Sumon (Department of Microbiology, Institute of Child Health) ;
  • Khobragade, Akash (Department of Medical & Clinical Pharmacology, Grant Govt. Medical College & Sir J.J. Group of Hospitals) ;
  • Thomas, Winston (Department of Pediatrics, Institute of Child Health) ;
  • Prabhudesai, Sumant (Department of Pediatric Intensive Care Unit, Kanchi Kamakoti Childs Trust Hospital) ;
  • Choudhary, Ankita (Department of Pediatrics, MGM Medical College) ;
  • Mitra, Monjori (Department of Pediatrics, Institute of Child Health)
  • Received : 2020.12.22
  • Accepted : 2021.05.20
  • Published : 2021.09.15
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Abstract

Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

Keywords

Acknowledgement

The authors would like to thank all the study subjects and their parents for participating in this study. The authors would like to acknowledge support of Medclin Research in the statistical analysis and manuscript development.

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