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

作     者：Christopher J Martoni Shalini Srivastava Anders Damholt Gregory J Leyer 

作者机构：Clinical DevelopmentHuman HealthChr.Hansen A/SHoersholm 2970Denmark Clinical DevelopmentVedic LifesciencesMumbai 400053India Scientific AffairsHuman HealthChr.Hansen A/SHoersholm 2970Denmark 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2023年第29卷第28期

页      面：4451-4465页

核心收录：

学科分类：1002[医学-临床医学] 10[医学] 

基　　金：Vedic Lifesciences team 

主　　题：Randomized clinical trial Diarrhea-predominant irritable bowel syndrome Microbiome Probiotic Lactiplantibacillus plantarum 

摘      要：BACKGROUND Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome(IBS-D);however,the certainty of evidence is low.Wellpowered 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 doseranging 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;P0.001)and L.plantarum 10B(-156.77±99.06;P0.001),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(P0.05).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(P0.001).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(P0.001).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.