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.