Original ArticleLack of an Effect of Lactobacillus reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: A Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Methods
The standards from the guidelines of the Consolidated Standards of Reporting Trials were followed for this randomized controlled trial (RCT). This trial was registered at ClinicalTrials.gov (NCT01046656). The study was approved by the Ethics Committee of the Medical University of Warsaw. Parents were fully informed about the aims of the study, and informed consent was obtained from at least 1 parent.
This was a prospective, randomized, double-blind, placebo-controlled trial conducted in the
Results
The Figure (available at www.jpeds.com) is a flow diagram showing the subjects’ progression through the study. Of the 106 children who underwent randomization, 54 were assigned to the probiotic group and 52 were assigned to the placebo group. Baseline demographic and clinical characteristics did not differ between the 2 groups (Table I). The outcome measures are summarized in Table II. We found no difference between the study groups with respect to the incidence of nosocomial diarrhea. Of the
Discussion
This study provides evidence that in hospitalized children, the administration of L reuteri DSM 17938 at a dose 108 CFU per day compared with placebo had no effect on the overall incidence of nosocomial diarrhea, including rotavirus infection.
The strengths of this study include adequate randomization, the use of a double-blind design, comprehensive follow-up, and the use of intention-to-treat analysis, all of which minimize the risk of bias. Considering the negative findings, one limitation of
References (17)
- et al.
CDC/NHSN surveillance definition of health careassociated infection and criteria for specific types of infections in the acute care setting
Am J Infect Control
(2008) - et al.
Infection control in paediatrics
Lancet Infect Dis
(2008) - et al.
Incidence of nosocomial rotavirus infections, symptomatic and asymptomatic, in breast-fed and non-breast-fed infants
J Hosp Infect
(2002) - et al.
Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants
J Pediatr
(2001) - et al.
Feeding of Bifidobacterium bifidum and Streptococcus thermophilus to infants in hospital for prevention of diarrhoea and shedding of rotavirus
Lancet
(1994) - et al.
Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study
J Pediatr
(2010) - et al.
Guidance for substantiating the evidence for beneficial effects of probiotics: current status and recommendations for future research
J Nutr
(2010) - et al.
European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe
J Pediatr Gastroenterol Nutr
(2008)
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Probiotics in pediatrics
2021, Probiotics: Advanced Food and Health ApplicationsProphylactic use of probiotics for gastrointestinal disorders in children
2019, The Lancet Child and Adolescent HealthCitation Excerpt :Sufficient evidence exists for showing that LGG administrated in a dose of at least 109 CFU per day during a hospital stay can significantly reduce the risk for nosocomial diarrhoea on a regular paediatric ward.28 Evidence of effectiveness of L reuteri DSM17938 in preventing nosocomial diarrhoea in children is absent.25,26 On the basis of currently available evidence, LGG can be recommended when the use of probiotics for preventing nosocomial diarrhoea in children is considered, as recommended by the Working Group on Probiotics from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition.29,30
Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: a randomized clinical trial
2019, Clinical Microbiology and InfectionCitation Excerpt :With regard to diarrhoeal diseases, the effective dosing remains unclear. Two earlier studies carried out by our group that evaluated the efficacy of using L. reuteri DSM 17938 at different doses (108 and 109 CFU/day, respectively) showed no effect in preventing nosocomial diarrhoea in children [24,25]. However, other studies have documented the effectiveness of L. reuteri DSM 17938 at a dose of 108 CFU/day both in the management of diarrhoeal diseases and other indications [26–28].
Lactobacillus reuteri
2017, The Microbiota in Gastrointestinal Pathophysiology: Implications for Human Health, Prebiotics, Probiotics, and DysbiosisIntestinal microbiota and susceptibility to viral infections: Role of probiotics
2016, Probiotics, Prebiotics, and Synbiotics: Bioactive Foods in Health Promotion
This study was funded by the Medical University of Warsaw, which received a donation from the manufacturer of L reuteri DSM 17938, BioGaia AB, Lund, Sweden. The manufacturer had no role in the conception, design, or conduct of the study, or in the analysis or interpretation of the data. The authors declare no conflicts of interest.
Registered at ClinicalTrials.gov: NCT01046656.