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Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome

BACKGROUND: Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the c...

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Autores principales: Martoni, Christopher J, Srivastava, Shalini, Damholt, Anders, Leyer, Gregory J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10415969/
https://www.ncbi.nlm.nih.gov/pubmed/37576702
http://dx.doi.org/10.3748/wjg.v29.i28.4451
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author Martoni, Christopher J
Srivastava, Shalini
Damholt, Anders
Leyer, Gregory J
author_facet Martoni, Christopher J
Srivastava, Shalini
Damholt, Anders
Leyer, Gregory J
author_sort Martoni, Christopher J
collection PubMed
description BACKGROUND: Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the clinical efficacy of Lactiplantibacillus plantarum (L. plantarum) Lpla33 (DSM34428) in adults with IBS-D. METHODS: This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or L. plantarum Lpla33 at 1 × 10(9) (1B) or 1 × 10(10) (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress. RESULTS: IBS-SSS was significantly reduced, after 8 wk, in participants receiving L. plantarum 1B (-128.45 ± 83.30; P < 0.001) and L. plantarum 10B (-156.77 ± 99.06; P < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the L. plantarum 10B group (P < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared to placebo (P < 0.001). Further, 62.5% and 88.4% of participants administered L. plantarum 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group (P < 0.001). In contrast, no significant shifts were observed in microbial diversity. CONCLUSION: L. plantarum Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.
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spelling pubmed-104159692023-08-12 Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome Martoni, Christopher J Srivastava, Shalini Damholt, Anders Leyer, Gregory J World J Gastroenterol Clinical Trials Study BACKGROUND: Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the clinical efficacy of Lactiplantibacillus plantarum (L. plantarum) Lpla33 (DSM34428) in adults with IBS-D. METHODS: This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or L. plantarum Lpla33 at 1 × 10(9) (1B) or 1 × 10(10) (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress. RESULTS: IBS-SSS was significantly reduced, after 8 wk, in participants receiving L. plantarum 1B (-128.45 ± 83.30; P < 0.001) and L. plantarum 10B (-156.77 ± 99.06; P < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the L. plantarum 10B group (P < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared to placebo (P < 0.001). Further, 62.5% and 88.4% of participants administered L. plantarum 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group (P < 0.001). In contrast, no significant shifts were observed in microbial diversity. CONCLUSION: L. plantarum Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D. Baishideng Publishing Group Inc 2023-07-28 2023-07-28 /pmc/articles/PMC10415969/ /pubmed/37576702 http://dx.doi.org/10.3748/wjg.v29.i28.4451 Text en ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.
spellingShingle Clinical Trials Study
Martoni, Christopher J
Srivastava, Shalini
Damholt, Anders
Leyer, Gregory J
Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title_full Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title_fullStr Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title_full_unstemmed Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title_short Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
title_sort efficacy and dose response of lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome
topic Clinical Trials Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10415969/
https://www.ncbi.nlm.nih.gov/pubmed/37576702
http://dx.doi.org/10.3748/wjg.v29.i28.4451
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