Evidence map›Paper›PMID 40712106›Full record

Trial reportNeurogastroenterology and motility2025

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.

O Kuzminska, B Vitkovska, Yurii Kuvaiskov, Chris G Hatton

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Neurogastroenterology and motility, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Irritable bowel syndrome with diarrhea: time to change practice?Current opinion in gastroenterology · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

O KuzminskaChernivtsi Hospital of Emergency Medical Care, Chernivtsi, Ukraine.
B VitkovskaHead of the Gastroenterology Department, TOV "GASTROTSENTR", Kyiv, Ukraine.
Yurii KuvaiskovMedical Writer, Verum Clinical Study LLC, Kyiv, Ukraine.
Chris G HattonFW Medical Ltd, Glasgow, UK.ORCID https://orcid.org/0009-0008-6959-2653

Funding

FW Medical Ltd and Delta Medical LLC
6 · The paper itself

Abstract

backgroundIrritable 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.

methodsAfter 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).

resultsFrom 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).

conclusionSilicolgel is safe and effective in IBS-D and IBS-M, providing an alternative to the limited treatments currently available.

Indexed as

Irritable Bowel SyndromeAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung Adultdouble‐blindenterosorbentirritable bowel syndromeplacebo‐controlled studyrandomized clinical trialRome IVsilicolgel

Identifiers

PMID40712106
PMCPMC12623281

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.