Safety and efficacy of purified clinoptilolite-tuff treatment in patients with irritable bowel syndrome with diarrhea:Randomized controlled trial  

作　　者：Karolina Anderle Michael Wolzt Gabriele Moser Bettina Keip Johannes Peter Claudia Meisslitzer Ghazaleh Gouya Michael Freissmuth Cornelius Tschegg 

机构地区：[1]Department of Clinical Pharmacology,Medical University of Vienna,Vienna 1090,Austria [2]Department of Internal Medicine III,Division of Gastroenterology and Hepatology,Medical University of Vienna,Vienna 1090,Austria [3]Glock Health,Science and Research GmbH,Deutsch-Wagram 2232,Lower Austria,Austria [4]Gouya Insights,Vienna 1010,Austria [5]Institute of Pharmacology and the Gaston H.Glock Research Laboratories for Exploratory Drug Development,Center of Physiology and Pharmacology,Medical University of Vienna,Vienna 1090,Austria

出　　处：《World Journal of Gastroenterology》2022年第46期6573-6588,共16页世界胃肠病学杂志（英文版）

基　　金：We thank myBioma GmbH for the microbiome analyses and designing the corresponding figures for the manuscript.

摘　　要：BACKGROUND Irritable bowel syndrome(IBS)is a highly prevalent gastrointestinal disorder with poor response to treatment.IBS with predominant diarrhea(IBS-D)is accompanied by abdominal pain as well as high stool frequency and urgency.Purified clinoptilolite-tuff(PCT),which is approved by the Food and Drug Administration for use as a dietary supplement with the brand name G-PUR®,has previously shown therapeutic potential in other indications based on its physical adsorption capacity.AIM To assess whether symptoms of IBS-D can be ameliorated by oral treatment with PCT.METHODS In this randomized,placebo-controlled,double-blind pilot study,30 patients with IBS-D diagnosis based on Rome IV criteria were enrolled.Following a 4-wk run-in phase,14 patients were randomized to receive a 12-wk treatment with G-PUR®(2 g three times daily),and 16 patients received placebo.The relief from IBS-D symptoms as measured by the proportion of responders according to the Subject’s Global Assessment(SGA)of Relief was assessed as the primary outcome.For the secondary outcomes,validated IBS-D associated symptom questionnaires,exploratory biomarkers and microbiome data were collected.RESULTS The proportions of SGA of Relief responders after 12 wk were comparable in both groups,namely 21%in the G-PUR®group and 25%in the placebo group.After 4 wk of treatment,36%of patients in the G-PUR®group vs 0%in the placebo group reported complete or considerable relief.An improvement in daily abdominal pain was noted in 94%vs 83%(P=0.0353),and the median number of days with diarrhea per week decreased by 2.4 d vs 0.3 d in the G-PUR®and placebo groups,respectively.Positive trends were observed for 50%of responders in the Bristol Stool Form Scale.Positive trends were also noted for combined abdominal pain and stool consistency response and the Perceived Stress Questionnaire score.Only 64%in the G-PUR®group compared to 86%in the placebo group required rescue medication intake during the study.Stool microbiome studies showed a minor increase in dive

关 键 词：Irritable bowel syndrome DIARRHEA Functional gastrointestinal disorder CLINOPTILOLITE ZEOLITE TREATMENT 

分 类 号：R574.4[医药卫生—消化系统]