Evidence map›Paper›PMID 41436948›Full record

Trial reportBMC gastroenterology2025

A study on the utility of inflammatory biomarkers in primary care irritable bowel syndrome: a sub analysis of the DOMINO randomized trial.

Celine Tack, Karen Van den Houte, Linde Besard, Luc Capiau, Steven Ceulemans, Olivier Gernay, Sophie Maes, Christian Peetermans, Willem Raat, Jeroen Stubbe and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04270487 (A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04270487 phase4completednot on this map

A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2018 to 2020Enrolled472ConditionsIrritable Bowel SyndromeArmsIBS Diet, Otilonium Bromide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

17 authors.

Celine TackTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
Karen Van den HouteTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
Linde BesardGastroenterology/Hepatology Unit, Leuven University Hospitals, Herestraat 49 box 701, Leuven, 3000, Belgium.
Luc CapiauPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Steven CeulemansPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Olivier GernayPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Sophie MaesPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Christian PeetermansPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Willem RaatPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Jeroen StubbePrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Rudy Van BoxstaelPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Olivia VandeputPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Sophie Van SteenbergenPrimary care physician, DOMINO primary care physician study group, Leuven, Belgium.
Bjorn GehesquièreCerba Healthcare Belgium - Labo CRI, Zwijnaarde, Belgium.
Jeroen RaesDepartment of Microbiology and Immunology, KU Leuven, Leuven, Flanders, Belgium.
Jan TackTranslational Research Center for Gastrointestinal Disorders, KU Leuven, Leuven, Belgium. jan.tack@kuleuven.be.
Florencia CarboneGastroenterology/Hepatology Unit, Leuven University Hospitals, Herestraat 49 box 701, Leuven, 3000, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of low-grade-inflammation in Irritable Bowel Syndrome (IBS) a common disorder of gut-brain interaction is unclear. Association with symptom severity, as well as effects of first line treatments are understudied. In a large cohort of primary care IBS patients (DOMINO trial), a FODMAP-lowering diet application was superior in improving symptoms compared to standard medical therapy (otilonium bromide, OB). We investigated the level of pro-inflammatory markers in this IBS cohort and its changes by the DOMINO application and OB.

methodsInflammatory markers fecal calprotectin (FC), secretory IgA (sIgA), beta-defensin 2 (HBD-2), fecal elastase (Fel-1), and C-reactive protein (CRP) were analyzed at baseline and after 8-week of treatment (diet or medication). In addition, patients filled out questionnaires to score IBS criteria (Rome IV), IBS subtypes, and symptom severity (IBS-SSS). We used Mann-Whitney-U test, Wilcoxon test, Spearman correlation, Kruskal Wallis test and Chi-square analysis to analyze our data.

resultsIn the DOMINO trial, stool and blood samples of 445 patients were collected before and after treatment. At baseline, respectively 9, 19, 15, 20, 2% of the patients showed abnormal levels of CRP, FC, sIgA, HBD-2, and Fel-1 compared to standard thresholds. However, these markers did not correlate with IBS-SSS. In addition, CRP was significantly lower in IBS-C patients compared to other IBS subtypes. After a 8-week treatment with a FODMAP lowering diet application, both HBD-2 and FC were significantly decreased, while only HBD-2 was decreased with OB.

conclusionInflammatory markers (FC, CRP, sIgA, HBD-2, Fel-1) were not correlated with symptom severity or predictive of treatment response to a FODMAP diet or OB treatment in a large primary care IBS cohort. All markers decreased after 8-week treatment, with significant differences for HBD-2 and FC. The anti-inflammatory effect of both treatments needs to be further investigated.

trial registrationThe trial was registered with ClinicalTrials.gov (NCT04270487, registered on 2020-05-04).

Indexed as

Diet, Carbohydrate-RestrictedIrritable Bowel SyndromeAdultbeta-DefensinsBiomarkersC-Reactive ProteinFecesFemaleHumansImmunoglobulin A, SecretoryLeukocyte ElastaseLeukocyte L1 Antigen ComplexMaleMiddle AgedPrimary Health CareSeverity of Illness Indexbeta-DefensinsBiomarkersC-Reactive ProteinDEFB4A protein, humanImmunoglobulin A, SecretoryLeukocyte ElastaseLeukocyte L1 Antigen ComplexDOMINO trialFODMAPIBSInflammatory markersOtilonium bromide

Identifiers

PMID41436948
PMCPMC12836962

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Registered trials

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.