Randomized Controlled Trial
Copyright ©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
Safety and efficacy of purified clinoptilolite-tuff treatment in patients with irritable bowel syndrome with diarrhea: Randomized controlled trial
Karolina Anderle, Michael Wolzt, Gabriele Moser, Bettina Keip, Johannes Peter, Claudia Meisslitzer, Ghazaleh Gouya, Michael Freissmuth, Cornelius Tschegg
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
Processing time: 163 Days and 22.1 Hours
ARTICLE HIGHLIGHTS
Research background

Irritable bowel syndrome with diarrhea (IBS-D) is a highly prevalent chronic gastrointestinal disorder with a substantial impact on quality of life. Despite the advancements in the available treatment, there is a need for effective therapy options with a favorable safety profile.

Research motivation

Previous studies have shown positive effects of clinoptilolite-tuff G-PUR® in multiple indications, especially for its adsorption capacity for a variety of toxins, heavy metals and other undesirable substances. Thus, clinoptilolite-tuff might be an effective therapy in IBS-D.

Research objectives

The primary objective of this clinical investigation was to assess the relief from IBS-D symptoms after a 12-wk treatment with G-PUR®. The main secondary objectives were to assess the safety and tolerability of treatment with G-PUR®, the impact of treatment on IBS-related symptoms, quality of life and additional exploratory parameters including microbiome analysis.

Research methods

We performed a randomized, placebo-controlled, double-blind pilot study on 30 patients with IBS-D. Over a treatment period of 12 wk, 14 patients received 2 g of G-PUR® three times daily, and 16 patients received placebo. The response was assessed with validated IBS-D associated symptom questionnaires. Exploratory biomarkers and microbiome data were collected and analyzed.

Research results

After 12 wk of treatment, the proportions of Subject’s Guide of Assessment of Relief responders were comparable in both groups, while after 4 wk of treatment significantly more patients in the G-PUR® group vs placebo group reported complete or considerable relief. An improvement in daily abdominal pain, diarrhea-free days, abdominal pain and stool consistency response was seen in the G-PUR® group compared to the placebo group.

Research conclusions

In this randomized, double-blind, placebo-controlled study, the purified clinoptilolite-tuff product G-PUR® demonstrated safety and clinical benefit towards some symptoms of IBS-D, representing a promising novel treatment option for these patients.

Research perspectives

Further research is needed to evaluate clinical efficacy of clinoptilolite-tuff product G-PUR® in larger cohorts.