Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome:A randomized,double-blind study

作     者：Michel Dapoigny Thierry Piche Philippe Ducrotte Bernard Lunaud Jean-Michel Cardot Annick Bernalier-Donadille 

作者机构：Médecine Digestive Centre Hospitalier Universitaire(CHU) EstaingCHU Clermont-FerrandClermont UniversitéInserm UMR 76663001 F-Clermont-FerrandFrance Department of Gastroenterology and Inserm 576Hpital de l'Archet 206202 NiceCedex 3France Department of Hepatogastroenterology and NutritionHpital Charles NicolleInserm UMR 107376031 RouenCedexFrance Department of GastroenterologyCentre République63000 Clermont-FerrandFrance Biopharmacy DepartmentFaculty of Pharmacy63000 Clermont-FerrandFrance UR454 Microbiology DivisionInstitut National de la Recherche AgronomiqueResearch Centre of Clermont-Ferrand-Theix63122 Saint Genès-ChampanelleFrance 

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

年 卷 期：2012年第18卷第17期

页      面：2067-2075页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Supported by Laboratoires Lyocentre 

主　　题：Irritable bowel syndrome Lactobacillus casei rhamnosus Probiotics Symptom severity score 

摘      要：AIM:To assess the effects and safety of Lactobacillus casei rhamnosus LCR35 complete freeze-dried culture(LCR35) in patients suffering from irritable bowel syndrome(IBS).METHODS:A randomized,double-blind pilot study was performed in 50 patients complaining of IBS symptoms complying with RomeⅢ*** were allocated to receive either LCR35(n = 25) at a minimum daily dose of 6 × 108 colony forming units or placebo(n = 25) for 4 *** inclusion,after treatment and 2 wk later,patients completed the IBS severity *** from baseline in the IBS severity score at the end of treatment was the primary efficacy *** were compared between groups in the whole population and in IBS subtypes(IBS with predominance of constipation,IBS with predominance of diarrhoea,mixed IBS,unsubtyped IBS).The presence of lactobacillus casei rhamnosus in stools was investigated at inclusion and at the end of *** gastrointestinal quality of life questionnaire and the hospital anxiety and depression(HAD) scale were also ***:Both groups were balanced for baseline *** 85% of patients,stool analyses showed that lactobacillus casei rhamnosus able to survive in the digestive *** the whole population,improvements in the IBS severity score did not differ significantly between treatments with a 25% decrease after 4-wk treatment,and a 15% decrease from baseline 2 wk later in both *** IBS subgroups,statistical analysis could not be performed due to small sample size,but a clinical response in favour of LCR35 was observed in IBS patients with predominance of diarrhoea:no change in the symptom severity score was seen with the placebo after 4 wk treatment,whereas a clinically relevant decrease occurred with LCR35(-37% vs-3%).Furthermore,in spite of an increase in symptom intensity,the IBS severity score was maintained below the baseline value 2 wk later with LCR35(-19% from baseline),whilst a slight 5% increase from baseline was observ