Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
09 Sep 2022
09 Sep 2022
Historique:
entrez:
10
9
2022
pubmed:
11
9
2022
medline:
14
9
2022
Statut:
ppublish
Résumé
The choice of an appropriate probiotic for pediatric acute gastroenteritis (PAGE) can be confusing. Our aim was to compare the efficacy and safety of 2 probiotics (Saccharomyces boulardii CNCM I-745 vs a 4-strain mixture of Bacillus clausii O/C, SIN, N/R, T) for the treatment of PAGE. A 2-arm parallel, randomized trial recruited children (6 months to 5 years old) with mild-moderate acute diarrhea, from 8 centers in Argentina. A total of 317 children were enrolled and blindly randomized to 5 days of either S boulardii CNCM I-745 (n = 159) or a 4-strain mixture of B clausii (n = 158), then followed for 7 days post-probiotic treatment. A stool sample was collected at inclusion for pathogen identification. The primary outcome was duration of diarrhea defined as the time from enrollment to the last loose stool followed by the first 24-hour period with stool consistency improvement. Secondary outcomes included frequency of loose stools/day, severity of diarrhea, number reporting no diarrhea at Day 6, time-to-first formed stool, recurrence of diarrhea by study end (Day 12) and safety outcomes. Three hundred twelve (98%) children completed the study. S boulardii CNCM I-745 showed a significant reduction (P = .04) in the mean duration of diarrhea (64.6 hours, 95% confidence interval [CI] 56.5-72.8) compared to those given B clausii (78.0 hours, 95% CI 69.9-86.1). Both probiotics showed improvement in secondary outcomes and were well-tolerated. In this study, S boulardii CNCM I-745 demonstrated better efficacy than B clausii mix for reducing the duration of pediatric acute diarrhea.
Sections du résumé
BACKGROUND
BACKGROUND
The choice of an appropriate probiotic for pediatric acute gastroenteritis (PAGE) can be confusing. Our aim was to compare the efficacy and safety of 2 probiotics (Saccharomyces boulardii CNCM I-745 vs a 4-strain mixture of Bacillus clausii O/C, SIN, N/R, T) for the treatment of PAGE.
METHODS
METHODS
A 2-arm parallel, randomized trial recruited children (6 months to 5 years old) with mild-moderate acute diarrhea, from 8 centers in Argentina. A total of 317 children were enrolled and blindly randomized to 5 days of either S boulardii CNCM I-745 (n = 159) or a 4-strain mixture of B clausii (n = 158), then followed for 7 days post-probiotic treatment. A stool sample was collected at inclusion for pathogen identification. The primary outcome was duration of diarrhea defined as the time from enrollment to the last loose stool followed by the first 24-hour period with stool consistency improvement. Secondary outcomes included frequency of loose stools/day, severity of diarrhea, number reporting no diarrhea at Day 6, time-to-first formed stool, recurrence of diarrhea by study end (Day 12) and safety outcomes.
RESULTS
RESULTS
Three hundred twelve (98%) children completed the study. S boulardii CNCM I-745 showed a significant reduction (P = .04) in the mean duration of diarrhea (64.6 hours, 95% confidence interval [CI] 56.5-72.8) compared to those given B clausii (78.0 hours, 95% CI 69.9-86.1). Both probiotics showed improvement in secondary outcomes and were well-tolerated.
CONCLUSION
CONCLUSIONS
In this study, S boulardii CNCM I-745 demonstrated better efficacy than B clausii mix for reducing the duration of pediatric acute diarrhea.
Identifiants
pubmed: 36086703
doi: 10.1097/MD.0000000000030500
pii: 00005792-202209090-00031
pmc: PMC9646502
doi:
Banques de données
ClinicalTrials.gov
['NCT03539913']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e30500Informations de copyright
Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
JA, MVC, AC, SMJ, CM, DM, LS and AS received fees from Biocodex as study investigators. They have no other conflict of interest to declare. FM and CJ are paid consultants to Biocodex. LVM is on the Microbiome Advisory Board and a paid lecturer for Biocodex, France and received a consulting fee for writing the manuscript. The sponsor (Biocodex, France) was involved in the study design, the analysis and interpretation of data, the writing of the report and the decision to submit the paper for publication.
Références
J Pediatr Gastroenterol Nutr. 1995 Apr;20(3):333-8
pubmed: 7608829
PLoS One. 2018 Dec 26;13(12):e0209205
pubmed: 30586435
Aliment Pharmacol Ther. 2019 Jun;49(11):1376-1384
pubmed: 31025399
Pediatr Infect Dis J. 2021 Aug 1;40(8):704-709
pubmed: 34250970
BMC Pediatr. 2009 Feb 06;9:11
pubmed: 19200366
Nutrients. 2021 Jun 24;13(7):
pubmed: 34202742
Biomed Pharmacother. 2019 Mar;111:537-547
pubmed: 30597307
World J Gastroenterol. 2019 May 14;25(18):2188-2203
pubmed: 31143070
Aliment Pharmacol Ther. 2020 Apr;51(7):678-688
pubmed: 32056266
Lancet Infect Dis. 2018 Nov;18(11):1211-1228
pubmed: 30243583
Cochrane Database Syst Rev. 2020 Dec 8;12:CD003048
pubmed: 33295643
Nutrients. 2018 Aug 12;10(8):
pubmed: 30103531
Front Med (Lausanne). 2018 May 07;5:124
pubmed: 29868585
J Fungi (Basel). 2020 Jun 04;6(2):
pubmed: 32512834
Front Microbiol. 2018 Jun 12;9:1230
pubmed: 29946306
J Pediatr Gastroenterol Nutr. 2020 Aug;71(2):261-269
pubmed: 32349041
Pediatrics. 2010 Jun;125(6):e1278-85
pubmed: 20439605
Nutrients. 2021 Nov 29;13(12):
pubmed: 34959871
J Coll Physicians Surg Pak. 2018 Mar;28(3):214-217
pubmed: 29544579
JPGN Rep. 2021 May 27;2(3):e079
pubmed: 37205949
J Pediatr Gastroenterol Nutr. 2020 May;70(5):694-701
pubmed: 32079974
Dig Dis Sci. 2020 Mar;65(3):706-722
pubmed: 32002758
Pediatr Infect Dis J. 2019 Sep;38(9):e228-e230
pubmed: 31033906
Pediatrics. 2014 Jul;134(1):e176-91
pubmed: 24958586
J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52
pubmed: 24739189
J Appl Microbiol. 2010 Nov;109(5):1745-52
pubmed: 20636342
J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):514-9
pubmed: 23676445
Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14
pubmed: 24912386
J Clin Epidemiol. 2010 Aug;63(8):e1-37
pubmed: 20346624
Trop Dis Travel Med Vaccines. 2019 Jul 23;5:14
pubmed: 31367461
Acta Paediatr. 2014 Feb;103(2):e91-2
pubmed: 24107091