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

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World Journal of Gastroenterology 2022年第46期28卷 6573-6588页

作者： Karolina Anderle Michael Wolzt Gabriele Moser bettina keip Johannes Peter Claudia Meisslitzer Ghazaleh Gouya Michael Freissmuth Cornelius Tschegg Department of Clinical Pharmacology Medical University of ViennaVienna 1090Austria Department of Internal Medicine III Division of Gastroenterology and HepatologyMedical University of ViennaVienna 1090Austria Glock Health Science and Research GmbHDeutsch-Wagram 2232Lower AustriaAustria Gouya Insights Vienna 1010Austria Institute of Pharmacology and the Gaston H.Glock Research Laboratories for Exploratory Drug Development Center of Physiology and PharmacologyMedical University of ViennaVienna 1090Austria

BACKGROUND Irritable bowel syndrome(IBS)is a highly prevalent gastrointestinal disorder with poor response to *** with predominant diarrhea(IBS-D)is accompanied by abdominal pain as well as high stool frequency and *** 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 *** To assess whether symptoms of IBS-D can be ameliorated by oral treatment with *** In this randomized,placebo-controlled,double-blind pilot study,30 patients with IBS-D diagnosis based on Rome IV criteria were *** 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 *** 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 *** the secondary outcomes,validated IBS-D associated symptom questionnaires,exploratory biomarkers and microbiome data were *** 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 *** 4 wk of treatment,36%of patients in the G-PUR®group vs 0%in the placebo group reported complete or considerable *** 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,*** trends were observed for 50%of responders in the Bristol Stool Form *** trends were also noted for combined abdominal pain and stool consistency response and the Perceived Stress Questionnaire *** 64%in the G-PUR®group compared to 86%in the placebo group required rescue medication intake during the *** microbiome

关键词： Irritable bowel syndrome Diarrhea Functional gastrointestinal disorder Clinoptilolite Zeolite Treatment

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