Comparative, randomized-controlled trial on efficacy and safety of Lactobacillus rhamnosus GG and Saccharomyces boulardii in treatment of acute diarrhea in Indian children (COMPARE-GG trial)

Abstract

Background: Probiotics are routinely prescribed to boost gut health and reduce severity of diarrhea. This study aimed to compare the efficacy and safety of Lactobacillus rhamnosus GG (LrGG) and Saccharomyces boulardii as an adjunct treatment for acute diarrhea in Indian children aged 6–36 months. Methods: In this single-center, open label, comparative, randomized controlled study, children were randomized into three groups (n=35, each) and provided either low osmolarity oral rehydration solution (ORS) and zinc (20 mg/day) alone or ORS+Zinc supplemented with one of the two probiotic preparations, LrGG ATCC 53103 or S. boulardii CNCM 1-745. Children were monitored every 8 hours after admission and the duration of diarrhea and hospital stay, and stool frequency were evaluated. Results: Of the total 105 children enrolled in the study, majority were aged between 13–24 months (40%). LrGG significantly reduced the mean duration of diarrhea by nearly 19 hours, when compared to the control group (p=0.003), while reduction by S. boulardii was not significant. The mean hospital stay duration for control group was about 6 days, which was significantly reduced (p=0.0001) by nearly 23 hours by LrGG, and non-significantly by S. boulardii. On day 2, LrGG significantly reduced stool frequency by 32.31%, as compared to 27.44% reduction in control group. S. boulardii reduced stool frequency by 31.76%, which was not statistically significant compared to that in control group. Conclusions: LrGG showed statistically significant reduction in duration of diarrhea and hospital stay, when compared against the group receiving ORS+zinc either alone or with S. boulardii.