Efficacy of an Oral Rehydration Solution Enriched with Lactobacillus reuteri DSM 17938 and Zinc in the Management of Acute Diarrhoea in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial.

The efficacy of oral rehydration solution (ORS) enriched with Lactobacillus reuteri DSM 17938 and zinc in infants with acute gastroenteritis, is poorly defined. The aim of this double-blind, randomized, placebo-controlled study, was to assess the efficacy of an ORS enriched with Lactobacillus reuteri DSM 17938 and zinc (ORS⁺Lr&Z) in well-nourished, non-hospitalized infants with acute diarrhoea. Fifty one infants with acute diarrhoea were randomly assigned to receive either ORS⁺Lr&Z (28 infants, mean ± SD age 1.7 ± 0.7 years, 21 males), or standard ORS (ORS-Lr&Z; 23 infants, mean ± SD age 1.8 ± 0.7 years, 16 males). Stools volume and consistency were recorded pre- and posttreatment using the Amsterdam Infant Stool Scale and were compared between the two groups, as well as lost work/day care days, drug administration and need for hospitalization. Both groups showed reduction in the severity of diarrhoea on day two (p < 0.001) while, all outcomes showed a trend to be better in the ORS⁺Lr&Z group, without reaching statistical significance, probably due to the relatively small number of patients. No adverse effects were recorded. In conclusion, both ORS were effective in managing acute diarrhoea in well-nourished, non-hospitalized infants. ORS enriched with L. reuteri DSM 17938 and zinc was well tolerated with no adverse effects.