Effectiveness of a multistrain synbiotic product in children with acute diarrhoea of probable viral etiology: multicentre prospective randomised controlled study.

Abstract

Acute diarrhoea in young children is very common and remains an important health problem. This study aimed to assess the effectiveness of a multistrain synbiotic compound in a drops formulation for treating acute diarrhoea of probable viral origin in children aged ≤2 years. A prospective, multicentre, randomised, open-label and controlled study was conducted in a cohort of 75 children (40 received a one-week treatment with a 7-multistrain synbiotic drops plus supportive therapy and 35 received supportive therapy alone). Based on the WHO definition of diarrhoea (≥3 loose/liquid stools/day) and the Bristol Stool Form Scale (BSFS) (stool consistency 5-7), a higher percentage of children in the synbiotic group experienced less diarrhoea (70%) vs controls (88.6%) ( P = 0.050). This statistically significant difference was present since day two of treatment. When diarrhoea was defined as ≥3 bowel movements/day for ≥3 consecutive days, diarrhoea was absent in 20% of children in the synbiotic group, whereas none of those in the control group was free of diarrhoea ( P = 0.006). The median days with diarrhoea was 4 (range 3-6.5) in the synbiotic group and 6 (range 5-7) in the control group ( P = 0.002). The use of this synbiotic product allowed children's diarrhoeal process to be shortened by two days and promoted a faster recovery. These results along a very favourable safety and tolerability profile supports the use of this multistrain synbiotic product in acute diarrhoea of suspected viral origin in children two years old or younger.