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

Abstract

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&amp;Z) in well-nourished, non-hospitalized infants with acute diarrhoea. Fifty one infants with acute diarrhoea were randomly assigned to receive either ORS⁺Lr&amp;Z (28 infants, mean ± SD age 1.7 ± 0.7 years, 21 males), or standard ORS (ORS^-Lr&amp;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&amp;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.

Keywords: Lactobacillus reuteri; acute gastroenteritis; children; oral rehydration solution; probiotics; zinc.

Figure 1

CONSORT flow diagram.

Figure 2

Improvement of the severity score of diarrhoea at day 2 compared to baseline (day⁻¹). At each time point, the results are presented with means and 95% confidence intervals. Comparisons within groups were performed by the Wilcoxon signed-rank test for paired data, whereas data between groups were compared by the Mann-Whitney U test. Comparisons in the ORS⁺Lr&Z arm on day two versus day⁻¹ (p < 0.001). Comparisons in the ORS⁻Lr&Z arm on day two versus day⁻¹ (p < 0.001).

Figure 3

Total six-day severity score of diarrhoea. Results are presented with means and 95% confidence intervals. Comparisons between the ORS⁺Lr&Z and the ORS^-Lr&Z arms were performed by the Mann-Whitney U test (p > 0.5).

Figure 4

(A): Number of days with watery stools. (B): Number of days with soft stools. Results are presented with means and 95% confidence intervals. Comparisons between the ORS⁺Lr&Z and the ORS^-Lr&Z arms were performed by the Mann-Whitney U test (p > 0.5).

Figure 5

(A): Number of lost day care/nursery days for patients. (B): Number of lost work days for parents. Results are presented with means and 95% confidence intervals. Comparisons between the ORS⁺Lr&Z and the ORS^-Lr&Z arms were performed by the Mann-Whitney U test (p > 0.5).