Lactobacillus rhamnosus GG Evaluation in Acute Diarrhea (LEAD): An Observational Study

Background and objective Probiotics with documented efficacy such as Lactobacillus rhamnosus GG(LGG) and Saccharomyces boulardii might be utilized as adjuncts to rehydration for the management of acute gastroenteritis (AGE) in children. In this study, we aimed to evaluate the potential role of LGG in acute diarrhea in the Indian pediatric population. Methods An observational, cross-sectional study [Lactobacillus rhamnosus GG Evaluation in Acute Diarrhea (LEAD)] was conducted among children aged one month to 12 years with acute watery diarrhea. In addition to standard management of diarrhea, LGG was given as an adjuvant treatment at the discretion of treating physicians based on their routine practice. Observations were documented on days one, three, and five. Outcomes such as frequency and duration of diarrhea, time to change in consistency of stools, Bristol Stool Chart (BSC) reading, and global assessment by healthcare practitioners (HCPs) and patients were also recorded. Results Of the 2,080 patients enrolled, 1,900 completed the five-day follow-up. There was marked improvement observed in the number of incidences of loose stools from day one (mean: 7.33) to day five (mean: 1.6). The mean time to improvement in stool consistency was 34 hours. The mean duration of diarrhea was 44.63 hours. A relatively shorter duration of diarrhea was reported among participants in this study. There was also a significant improvement in the number of vomiting episodes. Most patients and HCPs reported the product to be excellent/very good on the global assessment scale. No adverse effects were noted in any of the groups. Conclusion Based on our findings, LGG supplementation may be a beneficial adjuvant treatment in reducing the severity and duration of acute diarrheal episodes.