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

Abstract

IntroductionCertain 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.Methods and analysisA 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 Bifidobacterium (B. bifidum W23 and B. lactis W51) and six strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71 and L. salivarius 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 Clostridium difficile 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.Ethics and disseminationThe 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.Date and protocol version identifier14/10/2017.Trial registration numberNCT03334604; Pre-results.

Probiotic Strains and Intervention Total Doses for Modulating Obesity-Related Microbiota Dysbiosis: A Systematic Review and Meta-analysis

“…However, Bifidobacteria strains administered to animals were mainly administered by multistrain preparation, in the VSL#3*commercial product mixture of 8 probiotics strains: Lactobacillus acidophilus DSM24735, Lactobacillus plantarum DSM24730, Lactobacillus paracasei DSM24733 and Lactobacillus delbrueckii subsp. bulgaricus DSM24734; Streptococcus thermophilus DSM2473; Bifidobacterium breve DSM24732, Bifidobacterium longum DSM24736, Bifidobacterium infantis DSM24737 [ 44 ]; or in a common multispecies preparation with 9 strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58 [ 45 ].…”

Effect of a Multispecies Probiotic Mixture on the Growth and Incidence of Diarrhea, Immune Function, and Fecal Microbiota of Pre-weaning Dairy Calves

“…Multispecies probiotics [Lactobacillus acidophilus (McFarland et al, 2018;Łukasik and Szajewska, 2018), Bacillus subtilis (Rui and Ma, 2020), Saccharomyces cerevisiae (Thévenot et al, 2015)] have achieved certain results in human application, and there are similar reports in animals. Studies have found that Lactobacillus acidophilus (Sharma et al, 2018), Bacillus subtilis (Sun et al, 2010;Zhang et al, 2017;Wood et al, 2019), and Saccharomyces cerevisiae (Fomenky et al, 2018;Villot et al, 2019) can improve calf growth performance by improving immune function and balancing the structure of intestinal microbiota.…”

“…Probiotics are defined as "living organisms that bring health benefits to the host at an appropriate dose" (Hill et al, 2014). Multispecies probiotics (MSPs) were more effective than single-strain probiotics, especially in treating antibiotic-associated diarrhea in children (Ki et al, 2012;Łukasik and Szajewska, 2018), improving animal growth performance (Renaud et al, 2019), resisting bacterial infection (Perdigon et al, 1990;Avila et al, 1995;Lema et al, 2001;Woof and Kerr, 2006;Ehrenstein and Notley, 2010;Collumbien et al, 2012;Crassini et al, 2018), weight gain after stimulation post-enteritis (Renaud et al, 2019), and improving intestinal microbiota (Cruywagen et al, 1996;Chen et al, 2015;He et al, 2017;Hod et al, 2018;Biagioli et al, 2019).…”

Effects of Drugs and Excipients on Hydration Status

“…These authors observed that, although gastrointestinal disturbances were the most frequently reported adverse events, differences in the frequency of appearance were dependent on the posology (drug dosage and time interval between successive administrations). Probiotics are routinely employed in clinical practice to treat this diarrhea, and different mechanisms have been proposed to understand their effect, including the activity in the intestinal lumen (competition or direct suppression of pathogenic microorganisms), interactions with the mucosal barrier (up-regulation of tight junctions or modulation of water and ion channels) or influence on the intestinal immune system [83,155]. In addition to ADD, antimicrobial, specifically quinolones, led to many signs of other adverse reactions, such as loss of appetite [137], that may have potential consequences in WB.…”