Abstract and Introduction
Background Probiotics may be of help for the management of acute diarrhoea, however, the effect is strain specific and efficacy needs to be proven.
Aim To test the efficacy and safety of Lactobacillus reuteri DSM 17938 derived from L. reuteri ATCC 55730 in children with acute diarrhoea. Primary outcomes were the rate of unresolved diarrhoea after 3 days of treatment and duration of diarrhoea.
Methods Children (6–36 months), hospitalised in three paediatric hospitals in Southern Italy for acute diarrhoea with clinical signs of dehydration were randomised to receive in a double-blind fashion either L. reuteri (dose of 4 × 10 colony-forming units/die) or placebo.
Results Out of 96 eligible children, 74 were enrolled, five patients were withdrawn; 35 in the L. reuteri group and 34 in the placebo group. Lactobacillus reuteri significantly reduced the duration of watery diarrhoea as compared with placebo (2.1 ± 1.7 days vs. 3.3 ± 2.1 days; P < 0.03); on day two and three of treatment watery diarrhoea persisted in 82% and 74% of the placebo and 55% and 45% of the L. reuteri recipients respectively (P < 0.01; P < 0.03). Finally, children receiving L. reuteri had a significantly lower relapse rate of diarrhoea (15% vs. 42%; P < 0.03). There was not a significant difference in hospital stay between the groups. No adverse events were recorded.
Conclusion Our study shows that L. reuteri DSM 17938 as an adjunct to rehydration therapy is efficacious in the treatment of acute diarrhoea reducing the frequency, duration and recrudescence rate of the disease.
Acute gastroenteritis is generally defined as a decrease in the consistency of stools (loose or liquid) and/or an increase in the frequency of evacuations (typically more than 3 in 24 h), with or without fever or vomiting. Diarrhoea typically lasts less than 7 days and not longer than 14 days.
The incidence of acute diarrhoea ranges from 0.5 to 1.9 episodes per child per year in children younger than 3 years old in Europe, with Rotavirus being the most frequent agent.
Oral rehydration therapies (ORT) are the mainstay of management of acute diarrhoea. Although its composition continues to improve, the oral glucose-electrolyte rehydration solution (ORS) recommended by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and United Nations Children's Fund neither shortens the duration of the illness nor reduces the stool loss and may in fact increase the stool volume at least during the first hours in children with acute diarrhoea.
Probiotics may be an effective adjunct to the management of acute diarrhoea and a recent meta-analysis has shown that used alongside rehydration therapy, probiotics appear to be safe and have clear beneficial effects in shortening the duration and reducing stool frequency in acute infectious diarrhoea. However, more research is needed to guide the use of particular probiotic regimens and strain and as there is still no evidence of efficacy for many preparations, the ESPGHAN and the National Institute for Health and Clinical Excellence have suggested the use of probiotic strains with proven efficacy and in appropriate doses for the management of children with acute gastroenteritis as an adjunct to rehydration therapy.
Previously, in two separate prospective randomised trials Lactobacillus reuteri (L. reuteri) ATCC 55730 was shown to effectively colonise the gastrointestinal tract and to significantly shorten the duration of watery diarrhoea associated with rotavirus infection. Recently, this strain was found to carry specific, unusual, potentially transferable resistance traits for tetracycline and lincomycin, which led to the development of a new daughter strain, L. reuteri DSM 17938 derived from L. reuteri ATCC 55730 by the natural removal of these unwanted plasmid-borne resistances. The daughter strain retained the probiotic properties and its safety and tolerance in adults.
The aim of the present study was to assess the efficacy of this new strain of L. reuteri DSM 17938 as an adjunct to rehydration therapy in the treatment of children hospitalised with acute diarrhoea.