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

• Published in: Pediatric gastroenterology, hepatology & nutrition Vol. 24; no. 5; pp. 423 - 431
• Main Authors: Ghosh, Apurba, Sundaram, Balasubramaniam, Bhattacharya, Piyali, Mohanty, Nimain, Dheivamani, Nirmala, Mane, Sushant, Acharyya, Bhaswati, Kamale, Vijay, Poddar, Sumon, Khobragade, Akash, Thomas, Winston, Prabhudesai, Sumant, Choudhary, Ankita, Mitra, Monjori
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition 01.09.2021; 대한소아소화기영양학회
• Subjects: Original; 소아과학; Stool frequency; Diarrhea duration; Saccharomyces boulardii; Bacillus subtilis; Multi-strain probiotic; Acute gastroenteritis
• ISSN: 2234-8646; 2234-8840
• DOI: 10.5223/pghn.2021.24.5.423

To assess the effect of combination probiotic CNCM-I 3799 and CU-1 in outpatient management of acute watery diarrhea in children. 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 CNCM-I 3799 and 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. 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 ( <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 ( =0.017). CNCM-I 3799 and 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.