Efficacy and Safety of the Enterosorbent Silicolgel in Irritable Bowel Syndrome, IBS‐D and IBS‐M : A Randomized, Double‐Blind, Placebo‐Controlled, Multi‐Center Trial

ABSTRACT Background Irritable bowel syndrome (IBS) is a common gastrointestinal disorder significantly reducing quality of life. Silicolgel, a colloidal silicic acid enterosorbent, acts locally in the gut. This double‐blind, placebo‐controlled trial investigated its safety and efficacy in IBS‐D and IBS‐M, subtypes affecting over 60% of IBS sufferers. Methods After 2 weeks of screening, patients were randomized into 4 weeks of treatment, followed by a no‐medication phase to assess return of symptoms. Patients recorded bowel habits, abdominal pain, QoL, and global symptoms using weekly questionnaires and daily diaries. Primary outcome was a ≥ 50 point reduction in IBS Severity Scoring System (IBS SSS). Results From 139 adults with ROME IV IBS‐D or IBS‐M, 120 were randomized and all completed screening and treatment phases (silicolgel n = 60, placebo n = 60). After 4 weeks' treatment: 91.67% (ITT) achieved the primary outcome in the silicolgel group versus 20.00% for placebo (relative risk (RR) = 4.58, 95% CI 2.74–7.65, p < 0.001). Mean IBS SSS for silicolgel reduced to 92.75 [62.68], −162.87 versus 257.58 [74.94] +3.17 for the placebo group ( U = 210.5, r = 0.76, p < 0.001). Silicolgel also improved bowel habit, abdominal pain, distension, flatulence, and QoL. IBS‐D and IBS‐M patients showed the same improvements. Adverse events were similar in both groups, with no serious events attributable to silicolgel or placebo. Onset of action was rapid; after 2 weeks, 85.0% on silicolgel achieved the primary outcome versus 11.7% on placebo (significant difference). Conclusion Silicolgel is safe and effective in IBS‐D and IBS‐M, providing an alternative to the limited treatments currently available.