19 Jan Clinoptilolite Treatment for Patients with IBS: Randomized Controlled Trial
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.
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