Efficacy and tolerability of chitin-glucan combined with simethicone(GASTRAP^(■)DIRECT)in irritable bowel syndrome:A prospective,open-label,multicenter study  

作　　者：Nathalie Talbodec Pauline Le Roy Peggy Fournier Benoit Lesage Elodie Lepoutre François Castex Jean Michel Godchaux Lionel Vandeville Benjamin Bismuth Xavier Lesage Pauline Bayart Michael Genin Christel Rousseaux Veronique Maquet Salvatore Modica Pierre Desreumaux Caroline Valibouze 

机构地区：[1]Department of Gastroenterology,Hôpital privéLe Bois,Lille 59000,France [2]Department of Gastroenterology,Hôpital privéde Villeneuve d’Ascq,Villeneuve d’Ascq 59650,France [3]Univ.Lille,CHU Lille,ULR 2694–METRICS,Évaluation des Technologies de Santéet des Pratiques Médicales,Lille 59000,France [4]Development of Intestinal Biotech,1 Avenue Oscar Lambret,Lille 59045,France [5]KitoZyme SA,Parc Industriel des hauts Sarts Zone 2,Rue de Milmort,Herstal 4040,Belgium [6]BiOkuris A,Parc Industriel des hauts Sarts Zone 2,Rue de Milmort,Herstal 4040,Belgium [7]Department of Hepato-Gastroenterology,Lille University Hospital,Lille 59000,France [8]U1286-INFINITE,Institute for Translational Research in Inflammation,Univ.Lille,Inserm,CHU Lille,Lille 59000,France [9]Department of Digestive Surgery and Transplantation,Lille University Hospital,Lille 59037,France

出　　处：《World Journal of Gastrointestinal Pharmacology and Therapeutics》2024年第3期10-22,共13页世界胃肠药理与治疗学杂志（英文版）（电子版）

摘　　要：BACKGROUND Irritable bowel syndrome(IBS),defined according to the Rome IV diagnostic criteria,is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits.First-line recommended treatments are limited to combining drugs targeting predominant symptoms,particularly pain(antispasmodics),constipation(laxatives),and diarrhea(loperamide),yielding only a limited therapeutic gain.GASTRAP^(■)DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action.AIM To evaluate the efficacy,tolerability,and safety of 4-week GASTRAP^(■)DIRECT treatment in patients with IBS.METHODS In this prospective,multicenter,open-label trial,120 patients with IBS received three sticks of GASTRAP^(■)DIRECT(1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone)per day for 4 weeks.The primary endpoint was the responder rate,defined as the number of patients whose abdominal pain score decreased by≥30%from baseline to week(W)4.The analysis was performed using the per-protocol set.Cardinal symptoms,impact of global symptoms on daily life,change in stool consistency,and improvement in defecatory disorders were evaluated.RESULTS Overall,100 patients were evaluated.At W4,67%(95%CI:57-75)showed improvement in abdominal pain(score:5.8±2.4 vs 2.9±2.0,P<0.0001).Similar improvements were observed for bloating[8.0±1.7 vs 4.7±2.9,P<0.0001;60%(95%CI:50-70)responders],abdominal distension[7.2±2.1 vs 4.4±3.1,P<0.0001;53%(95%CI:43-63)responders],and impact of global symptoms on daily life[7.1±2.0 vs 4.6±2.9,P<0.0001;54%(95%CI:44-64)responders].Stool consistency improved in most patients(90%and 57%for patients with liquid and hard stools,respectively).Overall,42%of patients with defecatory disorders reported very much/considerable improvements by W2.No severe adverse event occurred,and tolerability was rated“good”or“very

关 键 词：Chitin-glucan Irritable bowel syndrome Abdominal pain FLATULENCE Defecatory disorders Stool consistency Natural non-pharmacological treatment 

分 类 号：R574.4[医药卫生—消化系统]