alexa Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acute diarrhoea--a double-blind study.
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Bioequivalence & Bioavailability

Author(s): Francavilla R, Lionetti E, Castellaneta S, Ciruzzi F, Indrio F,

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Abstract 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(8) 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 RESULTS: Out of 96 eligible children, 74 were enrolled, five patients were withdrawn; 35 in the L. reuteri group and 34 in the placebo group.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. © 2012 Blackwell Publishing Ltd. This article was published in Aliment Pharmacol Ther and referenced in Journal of Bioequivalence & Bioavailability

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