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Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis

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. ME...

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Autores principales: Altcheh, Jaime, Carosella, Mabel V., Ceballos, Ana, D’Andrea, Ulises, Jofre, Sandra M., Marotta, Carolina, Mugeri, Domingo, Sabbaj, Liliana, Soto, Adriana, Josse, Constant, Montestruc, Francois, McFarland, Lynne V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646502/
https://www.ncbi.nlm.nih.gov/pubmed/36086703
http://dx.doi.org/10.1097/MD.0000000000030500
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author Altcheh, Jaime
Carosella, Mabel V.
Ceballos, Ana
D’Andrea, Ulises
Jofre, Sandra M.
Marotta, Carolina
Mugeri, Domingo
Sabbaj, Liliana
Soto, Adriana
Josse, Constant
Montestruc, Francois
McFarland, Lynne V.
author_facet Altcheh, Jaime
Carosella, Mabel V.
Ceballos, Ana
D’Andrea, Ulises
Jofre, Sandra M.
Marotta, Carolina
Mugeri, Domingo
Sabbaj, Liliana
Soto, Adriana
Josse, Constant
Montestruc, Francois
McFarland, Lynne V.
author_sort Altcheh, Jaime
collection PubMed
description 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: 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: 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: In this study, S boulardii CNCM I-745 demonstrated better efficacy than B clausii mix for reducing the duration of pediatric acute diarrhea.
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spelling pubmed-96465022022-11-14 Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis Altcheh, Jaime Carosella, Mabel V. Ceballos, Ana D’Andrea, Ulises Jofre, Sandra M. Marotta, Carolina Mugeri, Domingo Sabbaj, Liliana Soto, Adriana Josse, Constant Montestruc, Francois McFarland, Lynne V. Medicine (Baltimore) Research Article 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: 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: 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: In this study, S boulardii CNCM I-745 demonstrated better efficacy than B clausii mix for reducing the duration of pediatric acute diarrhea. Lippincott Williams & Wilkins 2022-09-09 /pmc/articles/PMC9646502/ /pubmed/36086703 http://dx.doi.org/10.1097/MD.0000000000030500 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC) (https://creativecommons.org/licenses/by-nc/4.0/) , where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal.
spellingShingle Research Article
Altcheh, Jaime
Carosella, Mabel V.
Ceballos, Ana
D’Andrea, Ulises
Jofre, Sandra M.
Marotta, Carolina
Mugeri, Domingo
Sabbaj, Liliana
Soto, Adriana
Josse, Constant
Montestruc, Francois
McFarland, Lynne V.
Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title_full Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title_fullStr Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title_full_unstemmed Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title_short Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
title_sort randomized, direct comparison study of saccharomyces boulardii cncm i-745 versus multi-strained bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646502/
https://www.ncbi.nlm.nih.gov/pubmed/36086703
http://dx.doi.org/10.1097/MD.0000000000030500
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