Published online Dec 14, 2022. doi: 10.3748/wjg.v28.i46.6573
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
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.
To assess whether symptoms of IBS-D can be ameliorated by oral treatment with PCT.
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.
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 diversity in the G-PUR® group but not in the placebo group. No PCT-related serious adverse events were reported.
In this randomized, double-blind, placebo-controlled study, the PCT product, G-PUR®, demonstrated safety and clinical benefit towards some symptoms of IBS-D, representing a promising novel treatment option for these patients.
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.