Prospective Observational Study for the Evaluation of Efficacy and Safety Profile of Probiotics Food Supplement in Children with Acute Diarrhea

Background: Acute Diarrhea (AD) is the one of the most frequent gastroenterological disorders in pediatric age and if not properly treated it can lead to severe dehydration. Viral and bacterial infections or intoxications represent the primary causes of diarrhea and the consequent imbalance of intestinal microbiota exacerbates the pathological condition. In this case, the supplementation with probiotics could be useful, in order to improve the intestinal microenvironment, promote immunity and contrast the symptoms. Probiotics are able to reduce incidence of several types of diarrheas of different etiologies. Methods: In this multi-center, prospective, non-comparative observational study, we evaluated the efficacy and safety profile of a probiotic food supplement, composed by a mixture of lactic acid bacteria and live bifidobacteria (Bifidobacterium animalis ssp. Lactis DSM 33233 (Bi1), Bifidobacterium breve DSM 33231 (Bbr8), Streptococcus thermophilus LMG P-21908 (Z57), Lactobacillus acidophilus LMG P-21904 (LA1), Lacticaseibacillus rhamnosus DSM 29673 (CRL 1505) and Limosilactobacillus reuteri DSM 26866 (LR92)), in 44 children (age between 3 and 14 years) suffering from acute diarrhea and illness related to this pathological condition. Number of loose stools/days, stool consistency (Bristol Stool Scale, BSS), compliance to treatment and grade of dehydration (Gorelick scale) were evaluated as efficacy endpoints; adverse events were monitored to assess safety profile. Conclusions: The treatment with probiotics food supplement resulted significantly effective in 67.4% of children with acute diarrhea, at the end of treatment, measured as reduction of the number of loose stools per day and diarrhea duration. Moreover, the global health conditions were significantly improved in the 93% of patients. We confirmed that the treatment with probiotics food supplement could be an effective support for the recovery of children affected by acute diarrhea.