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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2022; 28(46): 6573-6588
Published online Dec 14, 2022. doi: 10.3748/wjg.v28.i46.6573
Published online Dec 14, 2022. doi: 10.3748/wjg.v28.i46.6573
Safety and efficacy of purified clinoptilolite-tuff treatment in patients with irritable bowel syndrome with diarrhea: Randomized controlled trial
Karolina Anderle, Michael Wolzt, Department of Clinical Pharmacology, Medical University of Vienna, Vienna 1090, Austria
Gabriele Moser, Bettina Keip, Johannes Peter, Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria
Claudia Meisslitzer, Cornelius Tschegg, Glock Health, Science and Research GmbH, Deutsch-Wagram 2232, Lower Austria, Austria
Ghazaleh Gouya, Gouya Insights, Vienna 1010, Austria
Michael Freissmuth, 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
Author contributions: Wolzt M, Moser G, Meisslitzer C, Gouya G and Tschegg C conceptualized the study; Wolzt M, Meisslitzer C, Gouya G, Freissmuth M and Tschegg C designed the methodology; Anderle K, Wolzt M, Moser G, Keip B and Peter J performed the investigation; Anderle K, Wolzt M, Moser G, Keip B, Peter J, Meisslitzer C, Gouya G, Freissmuth M and Tschegg C performed the data curation and reviewed/edited the manuscript for important intellectual content; Gouya G performed the formal analysis of data; Moser G and Freissmuth M performed the data validation; Anderle K wrote the original draft of the manuscript; Wolzt M and Tschegg C provided resources; Keip B and Peter J provided software; Anderle K, Meisslitzer C, Gouya G and Tschegg C performed project administration; Tschegg C and Meisslitzer C were responsible for funding acquisition; Wolzt M and Gouya G performed study supervision; All authors had access to the study data and reviewed and approved the final manuscript.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of Medical University of Vienna (No. 1295/2019), Ethics Committee of Upper Austria (No. 1208/2019) and the Austrian Federal Office for Safety in Health Care (BASG).
Clinical trial registration statement: This study was registered at ClinicalTrials.gov registry (Identifier NCT04138186).
Informed consent statement: All study participants provided verbal and written informed consent prior to study inclusion.
Conflict-of-interest statement: The Medical University of Vienna and Klinikum Wels-Grieskirchen were reimbursed for all trial-related work hours, material and effort spent by the study sponsor. Investigators or study staff did not receive any payment. Michael Freissmuth is the recipient of an unrestricted research endowment by G.H. Glock.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Michael Wolzt, MD, Professor, Department of Clinical Pharmacology, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria. michael.wolzt@meduniwien.ac.at
Received: June 27, 2022
Peer-review started: June 27, 2022
First decision: August 19, 2022
Revised: September 9, 2022
Accepted: November 16, 2022
Article in press: November 16, 2022
Published online: December 14, 2022
Peer-review started: June 27, 2022
First decision: August 19, 2022
Revised: September 9, 2022
Accepted: November 16, 2022
Article in press: November 16, 2022
Published online: December 14, 2022
Core Tip
Core Tip: The purified clinoptilolite-tuff (PCT) product, G-PUR®, provided improvement in abdominal symptoms and stool abnormalities in patients with irritable bowel syndrome (IBS) with predominant diarrhea. Additionally, it reduced the use of rescue medication and tended to enrich gut microbiome diversity compared to placebo, while showing no safety concerns. Hence, the PCT product, G-PUR®, represents a promising novel treatment option for patients with IBS with predominant diarrhea.