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Suárez Almarza J., García Marín F., García Menor E., Vecino López R., Horcajo Martínez G., Nieto Magro C.
ITF Research Pharma S.L.U, Madrid, Spain

Viral gastroenteritis is a common illness that occurs worldwide. In resource-limited settings, it is associated with considerable mortality and in developed countries, with substantial health-care costs. It is a clinical syndrome often defined by increased stool frequency, with or without vomiting. It usually lasts less than one week and not longer than two weeks and occurs throughout the year with a fall and winter predominance. Systematic reviews and meta-analyses of randomized trials of some probiotics have demonstrated a benefit in reducing stool frequency and the duration of diarrhea (by approximately one day), without increasing the risk of adverse effects. Synbiotics may be used for the management of acute viral diarrhea however, it was concluded in the 2014 Guidelines for the Management of Acute Gastroenteritis in Children in Europe that none of the synbiotics studied so far could be recommended until confirmatory data were available. The aim of this study was to evaluate the additional benefit of a synbiotic (Prodefen®) in the clinical management of acute viral diarrhea in children between 6 months and 12 years of age, attending to outpatient clinics or emergency departments. This synbiotic contains a combination of prebiotics (fructoolisaccarides) and 7 probiotic-strains (L.casei-PXN37, L.rhamnosus-PXN54, S.thermophilus-PXN66, B.breve-PXN25, L.acidophilus-PXN35, B.infantis-PXN27, L.bulgaricus-PXN39) 1x109 Colony Forming Units/sachet.

Multicenter, prospective, randomized and controlled study. Patients were randomized into two groups: control group receiving supportive treatment based on diet and oral rehydration therapy and synbiotic group receiving, in addition Prodefen®, 1 sachet/day for 7 days. Evolution of the diarrhea, tolerability and acceptance were evaluated after 7 days of treatment.

101 children between 6 months and 12 years of age were recruited; 43 children that received the synbiotic and 42 controls successfully completed the study. 79% of children in the synbiotic group vs 64% of controls (p=0.07) and 95% of children in the synbiotic group vs 78% of controls (p<0.001) did not present with diarrhea after 4 and 5 days of treatment, respectively. The shortening of the duration of diarrhea was of 1 day in children receiving synbiotic compared to controls (3vs4, p=0.377), and of 2 days in the subgroup of children from 6 months to 2 years of age (3vs5 p=0.034). During the study, 14% of children in synbiotic group and 26% of controls (p=0.15) had to reconsult to the physician. Significant differences on efficacy’s perception and tolerability’s evaluation were observed in children receiving the synbiotic vs controls, as 68% vs 28% of them found the treatment very or quite efficacious in the synbiotic vs control group, respectively and 67% vs 23% of them tolerated very well the treatment in the synbiotic vs control group, respectively. 95% of parents of children receiving the synbiotic reported being very satisfied/satisfied with the treatment.

Overall, the results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional clinical benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

Keywords: Synbiotic, Diarrhea, Gastroenteritis, Children, Probiotic

Suárez Almarza J., et al. (2016). Clinical evaluation of a synbiotic in pediatric patients with acute viral diarrhea. Conference Proceedings of IPC2016. Paper presented at the International Scientific Conference on Probiotics and Prebiotics, Budapest (p. 117.). IPC2016

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