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Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis
Stephen B Freedman1, Sarah Williamson-Urquhart1, Ken J Farion1
1From the Sections of Pediatric Emergency Medicine and Gastroenterology, Alberta Children's Hospital, Alberta Children's Hospital Research Institute (S.B.F.), and the Section of Pediatric Emergency Medicine, Alberta Children's Hospital (S.W.-U., J.X.), Cumming School of Medicine, University of Calgary, Calgary, the Departments of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa (K.J.F.), the Division of Pediatric Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal (S.G.), Ontario Child Health Support Unit, SickKids Research Institute, the Division of Biostatistics, Dalla Lana School of Public Health (A.R.W.), the Division of Gastroenterology, Hepatology, and Nutrition (P.M.S.), the Divisions of Pediatric Emergency Medicine and Clinical Pharmacology and Toxicology (Y.F.), and the Division of Pediatric Emergency Medicine and Research Institute (S.S.), Hospital for Sick Children, University of Toronto, Toronto, the Division of Emergency Medicine, London Health Sciences Centre, Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, ON (N.P.), the Division of Pediatric Emergency Medicine, IWK Health Centre, Halifax, NS (K.H.), the Department of Pediatrics, Faculty of Medicine and Dentistry, Women and Children's Health Research Institute (B.E.L.) and the Provincial Laboratory for Public Health-Alberta Public Laboratories and Department of Laboratory Medicine and Pathology (X.-L.P., L.C.), University of Alberta, Edmonton - all in Canada; the Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis (D.S.); and Children's Minnesota and Department of Pediatrics, University of Minnesota Medical School, Minneapolis (M.G.).
Insights
A combination probiotic did not prevent moderate-to-severe gastroenteritis in children visiting the emergency department. This study found no significant difference in outcomes between probiotic and placebo groups for pediatric gastroenteritis treatment.
Area of Science:
- Pediatric Emergency Medicine
- Gastroenterology
- Microbiome Research
Background:
- Gastroenteritis is a common cause of pediatric emergency department visits in the U.S., with 1.7 million annual visits.
- Limited data exist on the efficacy of probiotics for improving outcomes in children with gastroenteritis.
Purpose of the Study:
- To evaluate the effectiveness of a combination probiotic (Lactobacillus rhamnosus R0011 and L. helveticus R0052) in preventing moderate-to-severe gastroenteritis in children.
- To assess secondary outcomes including duration of symptoms, unscheduled healthcare visits, and adverse events.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in six Canadian pediatric emergency departments.
- 886 children aged 3 to 48 months with gastroenteritis received either the probiotic combination or a placebo for 5 days.
- The primary outcome was moderate-to-severe gastroenteritis, defined by a modified Vesikari scale score of 9 or higher within 14 days.
Main Results:
- No significant difference was observed in the incidence of moderate-to-severe gastroenteritis between the probiotic group (26.1%) and the placebo group (24.7%) (P=0.72).
- The probiotic intervention did not significantly reduce the duration of diarrhea or vomiting, nor did it decrease unscheduled healthcare visits or reported adverse events compared to placebo.
- Adjusted analysis confirmed that probiotic assignment did not predict moderate-to-severe gastroenteritis (P=0.74).
Conclusions:
- Twice-daily administration of a combined Lactobacillus rhamnosus and Lactobacillus helveticus probiotic did not prevent moderate-to-severe gastroenteritis in children presenting to the emergency department.
- The findings suggest that this specific probiotic combination is not effective in altering the course of acute gastroenteritis in this pediatric population.
- Further research may be needed to explore other probiotic strains or different therapeutic strategies for pediatric gastroenteritis.
Background:
Gastroenteritis accounts for approximately 1.7 million visits to the emergency department (ED) by children in the United States every year. Data to determine whether the use of probiotics improves outcomes in these children are lacking.
Methods:
We conducted a randomized, double-blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric EDs in Canada. Participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052, at a dose of 4.0×109 colony-forming units twice daily or placebo. The primary outcome was moderate-to-severe gastroenteritis, which was defined according to a post-enrollment modified Vesikari scale symptom score of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease). Secondary outcomes included the duration of diarrhea and vomiting, the percentage of children who had unscheduled physician visits, and the presence or absence of adverse events.
Results:
Moderate-to-severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants (26.1%) who were assigned to probiotics and 102 of 413 participants (24.7%) who were assigned to placebo (odds ratio, 1.06; 95% confidence interval [CI], 0.77 to 1.46; P=0.72). After adjustment for trial site, age, detection of rotavirus in stool, and frequency of diarrhea and vomiting before enrollment, trial-group assignment did not predict moderate-to-severe gastroenteritis (odds ratio, 1.06; 95% CI, 0.76 to 1.49; P=0.74). There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea (52.5 hours [interquartile range, 18.3 to 95.8] and 55.5 hours [interquartile range, 20.2 to 102.3], respectively; P=0.31) or vomiting (17.7 hours [interquartile range, 0 to 58.6] and 18.7 hours [interquartile range, 0 to 51.6], P=0.18), the percentages of participants with unscheduled visits to a health care provider (30.2% and 26.6%; odds ratio, 1.19; 95% CI, 0.87 to 1.62; P=0.27), and the percentage of participants who reported an adverse event (34.8% and 38.7%; odds ratio, 0.83; 95% CI, 0.62 to 1.11; P=0.21).
Conclusions:
In children who presented to the emergency department with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment. (Funded by the Canadian Institutes of Health Research and others; PROGUT ClinicalTrials.gov number, NCT01853124 .).
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