Evaluation Of The Efficacy And Safety Of Probiotic Formulation With Zinc Enriched Yeast In Children With Acute Diarrhea

Abstract

Background: Diarrhea is a common and potentially serious illness in early childhood. A child suffers, on an average, 10 to 15 episodes of diarrhea in the first five years of life. Particularly in developing countries like India this problem is much more common and also severe due to poor hygiene and less accessible healthcare facilities compared to western world. Objective: The objective of the study was to evaluate the efficacy and safety of a probiotic formulation with Zinc enriched yeast in children with acute diarrhea. Materials and Methods: This was an open label, non-randomized clinical trial conducted on outpatient basis by the qualified investigators at five different centers. A total of 104 pediatric patients (6-60 months of age) with acute diarrhea of < 48 hrs duration were enrolled in the study. The enrollment of the patients was as per inclusion/exclusion criteria. After obtaining informed consent they were individually examined, investigated and treated as per study protocol. The treatment included daily one sachet of Lactobacillus rhamnosus Rosell-11 (1Billion cells), Saccharomyces boulardii (125mg) along with Zinc enriched yeast (equivalent to elemental Zinc 20mg) for 1014 days. Results: Within studied population, 60% patients with acute diarrhea showed complete recovery from their symptoms by day 3, 35% by day 5 and remaining 5% of patients by day 10. These patients showed symptomatic improvement in all studied parameters which included, both stool frequency and consistency, episodes of vomiting and urination frequency. It was observed that 95 % of patients resumed normal food intake & activities in 5 days. As per investigator’s assessment, the efficacy of the treatment with trial medication was good and very good in 89 patients and satisfactory in 11 patients. Among the 100 patients studied, 20 patients rated the therapy with the trial medication as very good, 69 patients as good and 11 patients as satisfactory. All the patients reported good tolerability of the formulation with no serious adverse events. Conclusion: The present study concludes that once a day administration of probiotic-zinc combination containing Lactobacillus rhamnosus Rosell-11, Saccharomyces boulardii and zinc enriched yeast is effective in the treatment of acute diarrhea and associated symptoms. Source of support: The study was sponsored by Aristo Pharmaceuticals Pvt. Ltd. Mumbai.