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Therapeutic approach to DGBI: Drugs or diet?

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Therapeutic approach to DGBI: Drugs or diet?

Magnus Simrén 1

Affiliations

1 Sahlgrenska University Hospital - Dept of Internal Medicine, Sahlgrenska University Hospital ; Gothe, Gothenburg, Sweden

Summary

AI Generated

Dietary interventions appear effective as first-line treatment for IBS and may be more effective than pharmacological therapies, though the speaker recommends combining dietary, pharmacological, and behavioral approaches rather than choosing one over the other.

British Society of Gastroenterology and AGA guidelines recommend dietary advice early in IBS management, before pharmacological agents, starting with simple dietary guidelines and progressing to more restrictive diets if needed.
In the speaker's published study comparing low-carbohydrate diet and combined traditional IBS/low FODMAP advice versus optimized medical treatment, both dietary treatments showed better outcomes than drug treatment for overall and individual symptoms, with the most pronounced effect on bloating and sustained response at six months.
A Leuven study reported that patients receiving less restrictive FODMAP advice via smartphone app did better than those receiving the spasmolytic otilonium bromide.
Low FODMAP diet and traditional IBS dietary advice showed superiority over habitual diet in systematic reviews, though the Low FODMAP diet is restrictive and difficult to follow and can lead to unfavorable consequences without proper reintroduction.
Patient acceptability is important; simpler dietary advice was found more acceptable to shop for, cheaper, easier to follow, and more socially acceptable than highly restrictive diets.
The speaker expressed concern that restrictive diets can harm the microbiota and lead to excessive food avoidance, emphasizing that patients should not remain too strict long-term and should return as closely as possible to a normal varied diet.

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Abstract

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Small Intestine & Nutrition Primary Care

Session

Disorders of gut‐brain interaction: Dietary restrictions

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Pierre Raboisson

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UEG Presentation

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NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

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NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

Omesh Goyal 1, Manjeet Kumar Goyal 2, Prerna Goyal 3, Paraag Kumar 4, Ajit Sood 1

Affiliations

1 Dayanand Medical College and Hospital, Ludhiana, India

2 All India Institute of Medical Sciences, New Delhi, New Delhi, India

3 R.G. stone and superspeciality Hospital, Ludhiana, India

4 Maharishi Markandeshwar Institute of Medical Sciences and Research, Ambala, India

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Abstract

Introduction

Non-celiac gluten/wheat sensitivity (NCGWS) is characterized by gastrointestinal and extra-intestinal symptoms triggered by gluten/wheat ingestion. Symptoms of NCGWS overlap with those of irritable bowel syndrome (IBS) or functional dyspepsia (FD). Due to diagnostic challenges and symptom overlap, data on the prevalence and predictors of NCGWS among patients with IBS or FD, especially those with refractory symptoms, are limited.

Aims & Methods

This was a prospective, multicentric, double-blind, placebo-controlled, crossover trial conducted from October 2021 to March 2023 in India.This was prospectivly registered with the clinical trials Registry, INDIA (CTRI/2021/10/037323). Adults aged 18–65 years with Rome IV-defined irritable bowel syndrome (IBS) or functional dyspepsia (FD) refractory to standard treatment were enrolled after excluding celiac disease, wheat allergy, and alarm features. Participants underwent a two-step diagnostic protocol. In Step I, patients adhered to a 6-week strict gluten-free diet (GFD) under dietitian supervision. Weekly assessments of gastrointestinal and extra-intestinal symptoms, health-related quality of life (HRQoL), and psychological scores were performed using validated instruments. Gluten responders—defined by ≥30% reduction in one to three primary symptoms—were advanced to Step II: a randomized, double-blind, placebo-controlled gluten challenge with crossover. Subjects received indistinguishable gluten or placebo cookies (8 g/day) for one week, followed by a one-week washout and crossover. A ≥30% symptom difference between gluten and placebo phases confirmed non-celiac gluten/wheat sensitivity (NCGWS). Primary outcome was NCGWS prevalence; secondary outcomes included symptom and HRQoL changes post-GFD and predictors of NCGWS. Statistical analyses included intention-to-treat principles and multivariable regression to identify baseline predictors.

Results

Of the 252 patients screened, 177 were enrolled for 6-week GFD (step I), and 154 patients completed this phase (mean age 41.9±14.2 years, 53.2% males). Eighty two (52.3%) patients responded to GFD, of whom 77 entered step 2 (DBPCGC). Thirty one (20.1%) patients had significant symptom worsening on blinded gluten ingestion, suggesting the presence of NCGWS. Independent predictors of NCGWS were female gender, FD-IBS overlap, headache, fatigue, and anxiety. Significant improvements in gastrointestinal symptoms, health-related quality of life, and psychological scores were observed after GFD in responders. No significant impact of diet sequence was noted.

Variable	Univariable regression	Multivariable regression
Variable	OR (95% CI)	p value	OR (95% CI)	p value
Female gender	1.661 (1.236–2.261)	< 0.001	1.519 (1.041–2.036)	0.028
Abdominal pain	0.354 (0.081–1.422)	0.451
Abnormal stool consistency	1.238 (1.033–1.521)	0.004	1.334 (1.022–2.551)	0.512
Bloating	1.433 (1.073–3.571)	0.031	0.889 (0.541–2.391)	0.093
Dyspepsia - Irritable bowel syndrome Overlap	4.442 (1.613–9.441)	< 0.001	2.056 (1.131–3.031)	0.031
Headache	2.117 (1.028–5.516)	0.029	0.615 (0.315–1.318)	0.044
Fatigue	4.117 (2.027–8.134)	< 0.001	1.073 (1.022–1.191)	0.012
Anxiety	2.724 (1.033–5.769)	0.018	1.992 (1.741–2.014)	0.037

Conclusion

Approximately one-fifth of patients with refractory IBS or FD were diagnosed with non-celiac gluten/wheat sensitivity (NCGWS) using a structured double-blind, placebo-controlled gluten challenge. Identification of NCGWS is essential to avoid unnecessary pharmacotherapy and to enable targeted dietary interventions. A gluten-free diet significantly improved gastrointestinal and extra-intestinal symptoms, as well as quality of life, highlighting the need for precise diagnostic strategies in clinical practice.

Event

UEG Week Berlin 2025

Topics

Immunology Neurogastroenterology & Motility Small Intestine & Nutrition Oesophagus Stomach & H. Pylori

Submission format

Abstract

Session

Complexity and diversity in upper GI

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Pierre Raboisson

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UEG Presentation

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Gut-brain chaos: Here’s how primary care can restore order

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Gut-brain chaos: Here’s how primary care can restore order

Christos D Lionis 1

Affiliations

1 University of Crete, Heraklion, Greece

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Paediatrics Standards & Guidelines Stomach & H. Pylori

Session

From guidelines to clinical practice: The gut-brain connection - PPIs and guideline application in clinical practice

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

Ajit Sood

Gut-brain chaos: Here’s how primary care can restore order

Christos D Lionis

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Giovanni Sarnelli

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Pierre Raboisson

Exploiting the immune response in GI cancer: Next chapter

Tamara Matysiak-Budnik

UEG Presentation

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What the gastroenterologist can offer

Giovanni Sarnelli 1

Affiliations

1 University of Naples 'Federico II', Pozzuoli NA, Italy

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Abstract

Event

UEG Week Berlin 2025

Topics

Neurogastroenterology & Motility Primary Care

Session

Therapy update: Dyspepsia

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Guiding diagnosis and therapy using proteomics

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Guiding diagnosis and therapy using proteomics

Knut E.A. Lundin 1

Affiliations

1 Norwegian Coeliac Disease Research Centre, University of Oslo and Oslo University Hospital, Oslo, Norway

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Abstract

Event

UEG Week Berlin 2025

Topics

Mechanisms & Personalised Medicine

Session

The art of making clinical research precise: Biomarkers of the future - Is it liquid gold?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

Ajit Sood

Gut-brain chaos: Here’s how primary care can restore order

Christos D Lionis

What the gastroenterologist can offer

Giovanni Sarnelli

Guiding diagnosis and therapy using proteomics

Knut E.A. Lundin

DISCOVERY OF A NOVEL, SELECTIVE SIK3 INHIBITOR FOR THE TREATMENT OF ULCERATIVE COLITIS, CROHN'S DISEASES AND OTHER AUTOIMMUNE DISEASES

Pierre Raboisson

Exploiting the immune response in GI cancer: Next chapter

Tamara Matysiak-Budnik

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

DISCOVERY OF A NOVEL, SELECTIVE SIK3 INHIBITOR FOR THE TREATMENT OF ULCERATIVE COLITIS, CROHN'S DISEASES AND OTHER AUTOIMMUNE DISEASES

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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DISCOVERY OF A NOVEL, SELECTIVE SIK3 INHIBITOR FOR THE TREATMENT OF ULCERATIVE COLITIS, CROHN'S DISEASES AND OTHER AUTOIMMUNE DISEASES

Fabrice KOLB 1, John-Paul Gallivan 1, Steve De Vos 2, Nicolas Desroy 2, David Moreno 2, Michael Torok 2, Anouk Blauw 2, Christian Seemayer 2, Emmanuel Karouzakis 2, Chantal Tasset 2, Christophe Peixoto 3, Didier Merciris 3, Catherine Jagerschmidt 3, Adrien Cosson 3, Stéphanie Lavazais 3, Wulf-Otto Boucher 2, Pierre Raboisson 1

Affiliations

1 Onco3R Therapeutics, Leuven, Belgium

2 Galapagos NV, Mechelen, Belgium

3 Novalix, Romainville, France

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Abstract

Introduction

Current treatment options for IBD are limited by low clinical remission rates and loss of response. Most therapies target single pathogenic pathways and while combinations of biologics targeting different pathogenic cytokines can increase clinical remission rates, dosing schedules are inconvenient. JAK inhibitors, target multiple cytokine pathways, but are limited by safety concerns.
Salt-inducible kinases (SIKs) are a subfamily of serine/threonine kinases in the AMP-activated protein kinase (AMPK) family and act as key regulators of immune cell signaling. SIK inhibitors have been shown to target multiple cytokine pathways.
Three SIK isoforms exist: SIK1, SIK2 and SIK3. SIK inhibitors targeting multiple isoforms have been investigated in clinical trials. Although there have been signals of activity in patients with ulcerative colitis and psoriasis, limited efficacy and safety concerns related to SIK1 and 2 inhibition have hampered their development.

Aims & Methods

We performed structure based drug design to identify highly potent and selective SIK3 inhibitors that could offerbest in class efficacy and safety for the treatment of various auto-immune diseases. Our effort led to to the discovery of 100s of compounds spanning SIK3 binding sites. Compounds were tested in protein and cell-based assays to evaluate potency and selectivity against SIK3 and in a phenotypic human whole blood TNFα assay. Lead optimization involving rigorous testing in safety and pharmacology panels, resulted in the selection of lead candidates that were tested in a variety of translational models to identify the most efficacious compounds. Human PK predictions were performed using non-clinical in vivo PK assessments and allometric scaling leading to the selection of the drug candidate, which entered GLP toxicology studies.

Results

O3R-5671 is a highly potent and specific SIK3 inhibitor with sub-nanomolar potency for SIK3 and low activity against SIK1 and 2 and over all human kinases. It demonstrated potent activity in a panel of human primary phenotypic cell assays inhibiting TNFα, IL-12, and IL-23 release in LPS-stimulated myeloid cells, and inhibiting TNFa release in LPS-stimulated human whole blood. O3R-5671 also inhibited activation of TCR-stimulated human primary T cells and induced IL-10 secretion from myeloid cells.
In vivo, O3R-5671 demonstrated dose-dependent activity in a mouse LPS challenge model, dose-dependent efficacy in two distinct mouse models of IBD, and dose-dependent efficacy in mouse models of IL-23-induced psoriasis and psoriatic arthritis. Cross-species PK and allometric scaling were used to predict O3R-5671’s human PK profile- which is expected to be conducive to potent SIK3 inhibition and clinical efficacy in patients with IBD.
O3R-5671 demonstrated a highly attractive profile in ADME and in vitro safety panels. Six-week GLP toxicity studies in rats and dogs established no observed adverse effect levels (NOAELs) which support dosing in humans with doses that are predicted to be pharmacologically active with a large safety margin.

Conclusion

O3R-5671 is a highly specific and potent SIK3 inhibitor that is predicted to have a flat PK profile in humans. These properties should allow O3R-5671 to apply strong drug pressure on SIK3 while sparing SIK1 and 2. This is expected to result in the inhibition of multiple pathogenic cytokines including TNFa and IL-23, both of which have been validated as IBD targets. A clinical trial is ongoing to establish the safety and PK profile of O3R-5671 and understand its effect on pharmacodynamic biomarkers.

Disclosure

All authors were employed by Galapagos who discovered O3R-5671 or Novalix, a CRO that was employed by Galapagos. Some authors are employed by Onco3R therapeutics, who are currently developing O3R-5671

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD Mechanisms & Personalised Medicine

Submission format

Late-Breaking Abstract

Session

Hot off the press: IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

Ajit Sood

Gut-brain chaos: Here’s how primary care can restore order

Christos D Lionis

What the gastroenterologist can offer

Giovanni Sarnelli

Guiding diagnosis and therapy using proteomics

Knut E.A. Lundin

DISCOVERY OF A NOVEL, SELECTIVE SIK3 INHIBITOR FOR THE TREATMENT OF ULCERATIVE COLITIS, CROHN'S DISEASES AND OTHER AUTOIMMUNE DISEASES

Pierre Raboisson

Exploiting the immune response in GI cancer: Next chapter

Tamara Matysiak-Budnik

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Exploiting the immune response in GI cancer: Next chapter

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Exploiting the immune response in GI cancer: Next chapter

Tamara Matysiak-Budnik 1

Affiliations

1 CHU de Nantes IMAD, Nantes, France

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Abstract

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Hepatobiliary Immunology Mechanisms & Personalised Medicine Small Intestine & Nutrition

Session

The art of making clinical research precise: What will be new in therapy in 2030?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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NON-CELIAC WHEAT SENSITIVITY IN REFRACTORY FUNCTIONAL DYSPEPSIA AND IRRITABLE BOWEL SYNDROME: A PROSPECTIVE, RANDOMIZED STUDY

Ajit Sood

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Christos D Lionis

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Giovanni Sarnelli

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UEG's educational platform for gastroenterology education bringing recordings, courses, guidelines, and more together in one place.

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