Abstract:
Background: Probiotics are shown to be beneficial in the management of acute diarrhea in children, the major cause of morbidity and mortality in children under five. European Society for Paediatric Infectious Diseases (ESPID) and European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPHAN) guidelines recommend use of probiotics such as Lactobacillus rhamnosus GG and Saccharomyces boulardii as an adjunct to rehydration therapy for acute gastroenteritis in children. This observational study was conducted to evaluate benefits of supplementation with Saccharomyces boulardii 250 mg (5 billion CFUs) plus Lactobacillus rhamnosus GG 5 billion CFUs (Sporit GG™) in acute diarrhea in a real world setting.
Methods: Children up to 12 years of age, presenting with acute diarrhea, who were eligible to receive Sporit GG™ per the treating physician were included in the study. Sporit GG™ was recommended in the dose of 1- 2 sachet(s)/day for up to 5 days by the treating physician. Patients also received oral rehydration solution (ORS), zinc and/or antibiotics at the discretion of physician. Duration of diarrhea was defined as duration in days between first and last loose stool. Frequency of stools was recorded from Day 0 to 5. Effectiveness of Sporit GG™ was assessed based on effect on duration and frequency of diarrhea. Details of adverse events, if any were recorded. The study was registered on Clinical Trial Registry, India (CTRI/2020/03/023736).
Results: Between March and October 2020, 300 subjects with acute diarrhea who were recommended with Sporit GG™ supplementation were enrolled at 8 centres across India. Of these, 297 subjects consumed Sporit GG™ along with standard of care, as recommended. About 60% subjects were in 0-2 years age-group. All 300 subjects enrolled in the study were included in effectiveness assessment. Supplementation with Sporit GG™ significantly reduced the frequency of diarrhea, irrespective of type of diarrhea, by 62.2%, 79.7% and 92.8% on 2, 3 and 5 days from baseline, respectively (6.5±2.4 on Day 0 to 0.6±0.8 on Day 5; p<0.001). Mean duration of diarrhea was 2.54±1.21 days. This is in line with previously reported studies, wherein supplementation with Lactobacillus rhamnosus GG 10 billion CFUs/day reduced the duration of diarrhea by nearly 30% (5.02 days in Lactobacillus group vs 7.23 days in control group) when compared with control, and frequency of diarrhea was reduced by 59% in Lactobacillus group and by 30% in the control group by Day 3 (Basu S et al. J Clin Gastroenterol. 2009;43:208-13).
Tolerability assessment was performed on all enrolled patients who received at-least 1 dose of Sporit GG™ (n=297). Five patients reported AEs (macular rash, [3 subjects], mild rash [1 patient], stomach pain [1 patient]); all were mild in intensity. No serious AEs were reported and overall, Sporit GG™ was well-tolerated.
Conclusion: This multicentre, real-world study demonstrates effectiveness and tolerability of supplementation with Saccharomyces boulardii 250 mg (5 billion CFUs) plus Lactobacillus rhamnosus GG 5 billion CFUs (Sporit GG™) in children up to 12 years of age with acute diarrhea. Further randomized, controlled clinical studies are recommended to confirm these findings.
What will audience learn from your presentation?
• This study adds to the knowledge about real-world effectiveness and tolerability profile of supplementation with combination of Saccharomyces boulardii 250 mg (5 billion CFUs) plus Lactobacillus rhamnosus GG 5 billion CFUs (Sporit GG™) for acute diarrhea.
• This is the first study in Indian patients documenting the real-world effectiveness and tolerability of combination of Saccharomyces boulardii 250 mg (5 billion CFUs) plus Lactobacillus rhamnosus GG in children with acute diarrhea.
• This real-world study demonstrates utility of combination of Saccharomyces boulardii 250 mg (5 billion CFUs) plus Lactobacillus rhamnosus GG in reducing frequency and duration of diarrhea in children with acute diarrhea.
