Effect of a multispecies probiotic on reducing the incidence of antibiotic-associated diarrhoea in children: a protocol for a randomised controlled trial.

Abstract

Certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics (MPs) remain unclear. We aim to assess the effectiveness of a specific MP preparation (Winclove 612) in reducing the incidence of AAD in children. A total of 350 children aged 6 months to 18 years, undergoing antibiotic treatment, will be randomly allocated to receive either a MP consisting of two strains of <i>Bifidobacterium</i> (<i>B. bifidum</i> W23 and <i>B. lactis</i> W51) and six strains of <i>Lactobacillus</i> (<i>L. acidophilus</i> W37, <i>L. acidophilus</i> W55, <i>L. paracasei</i> W20, <i>L. plantarum</i> W62, <i>L. rhamnosus</i> W71 and <i>L. salivarius</i> W24) at a total dose of 10¹⁰ colony-forming units daily, or a placebo, from the first day of antibiotic treatment until 7 days after antibiotic cessation, up to a maximum of 17 days. The primary outcome will be the incidence of AAD, defined as ≥3 loose or watery stools (a score of A on the Amsterdam Infant Stool Scale or a score of 5-7 on the Bristol Stool Form scale) in 24 hours, caused either by <i>Clostridium difficile</i> or of otherwise unexplained aetiology, occurring during the intervention period. The secondary outcomes will include the incidence of AAD according to alternative definitions; the incidence of any kind of diarrhoea; the duration of diarrhoea; the need for hospitalisation; intravenous rehydration or discontinuation of antibiotic treatment due to diarrhoea; adverse events; and the intestinal microbiota composition. The study protocol is approved by the Ethics Committee of the Medical University of Warsaw. The findings will be published in a peer-reviewed journal and submitted to relevant conferences. 14/10/2017. NCT03334604; Pre-results.