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Introduction

Helicobacter pylori is class I carcinogen responsible for 89% of non cardia gastric cancer.

Aims & Methods

Screen and treat application study is ongoing in six EU countries in the asymptomatic age group of citizens from the age of 30 to 34 years. The test-and-treat program is free of charge for all eligible participants. Four different locally validated H. pylori IgG serologies and / or UBT as a test were used. Quadruple bismuth based 14 day, a 10-day regimen with esomeprazole combined with bismuth quadruple therapy in a single-capsule or 14 day tripple eradication therapy were used as the first line therapy. RED Cap IT platform (pretreatment questionnaires, treatment protocols, side effects, compliance,complications…) was used to collect data for quality assurance, monitoring, and evaluation.

Results

The study is still ongoing. Interim results show a wide variation of response rates to the invitation (from 4,1% in Wroclaw to 45,5% in Ljubljana). Seropositivity / UBT rates vary from 13,9% in Ljubljana to 49% in Latvia. The eradication rates are from 88,2% in Dublin to 96,9% in Ljubljana. The use of all three treatment schemes showed encouraging eradication and adherence rates, whereas the incidence of adverse events due to this therapy was within the acceptable range. No serious adverse events have been reported so far. The differences among study sites are in the organisation of invitations, educational campaigns and dissemination activities as well as in the time when study was launched in a certain country.

Conclusion

The screen and treat application study is organised in a way as an organised cancer screening program. Careful study planning: legal, financial, technical, organisational aspect and public awareness campains should be implemented before official lounch of the study.Central data capture system is necessary to implement quality control monitoring. Education and public awareness campaign to increase the participation rate are of crucial importance.

TOGAS – TOWARDS GASTRIC CANCER SCREENING IMPLEMENTATION IN THE EUROPEAN UNION – WP 4 PILOT STUDY

Bojan Tepes 1, Tatjana Kofol Bric 2, Tea Stegne Ignjatovič 3, Antonija Poplas Susič 3, Charlene Deane 4, Colm O'Morain 5, Marcis Leja 6, Radu-Alexandru Farcas 7, Dan Lucian Dumitrascu 8, Katarzyna Neubauer 9, Mirjana Kalauz 10, SANDRA MILIC 11, Mitja Oblak 2, Marcel Kralj 2

1 National Institute of Public Health, Ljubljana, Slovenia|||DC Rogaska, Rogaska Slatina, Slovenia

2 NIJZ, Ljubljana, Slovenia

3 CHC Ljubljana, Ljubljana, Slovenia

4 Connolly Hospital, Beacon Hospital, Dublin, Ireland

5 Trinity College Dublin - Faculty of Health Sciences, Trinity College Dublin; Dublin/IE, Dublin, Ireland

6 University of Latvia, Riga, Latvia

7 Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

8 Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania

9 University Clinical Center, Wroclaw, Poland

10 Clinical Hospital Center Zagreb, Zagreb, Croatia

11 KBC Rijeka, Rijeka, Croatia

Conference

UEG Week Berlin 2025

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

H. pylori and gastric cancer (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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THE RESISTANT MICROBIOME: INSIGHTS FROM POUCHITIS AND HEALTHY ILEAL POUCHES

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Introduction

Chronic pouchitis is a common complication following ileal pouch-anal anastomosis (IPAA), with limited effective treatment options.¹ Antibiotics remain the first-line therapy; however, in cases of chronic pouchitis, prolonged antibiotic use contributes to increased antimicrobial resistance within the ileal pouch microbiome.² Fecal microbiota transplantation (FMT) has been proposed as a means of restoring microbial balance. Nevertheless, randomized placebo-controlled trials have demonstrated that, although FMT can alter the microbiome, it does not confer clinical benefits compared to placebo.^3–5

Aims & Methods

Given the lack of efficacy of FMT using stool from healthy donors, the present study aims to characterize the microbiome of a healthy ileal pouch and to evaluate the impact of high antibiotic exposure in patients with chronic pouchitis.
In this cohort study, stool samples were collected from four groups: patients with a normally functioning IPAA, patients with chronic pouchitis, patients with ulcerative colitis, and healthy controls. Microbiome composition and antibiotic resistance genes were analyzed across these groups. Fecal samples underwent metagenomic sequencing, and metagenome-assembled genomes (MAGs) were reconstructed. For Escherichia coli MAGs, the antibiotic resistance gene (ARG) profiles and plasmid content were specifically examined.

Results

This study included 197 participants. A clear pattern emerged in the microbial composition, revealing that reduced alpha diversity is directly associated with declining gut function and clinical health. Both species richness and Shannon diversity were lowest in patients with chronic pouchitis and highest in healthy individuals, with intermediate levels observed in the other groups. Notably, the ileal pouch microbiome of many chronic pouchitis patients was dominated by E. coli. Given the potential clinical implications of high E. coli abundance, we further investigated the ARG profiles and plasmid content of E. coli MAGs. E. coli MAGs from chronic pouchitis patients exhibited a significantly higher frequency of single nucleotide polymorphisms (SNPs) associated with resistance to fluoroquinolones—an antibiotic uniformly used among this patient group—compared to MAGs from the normally functioning IPAA and healthy control cohorts. Furthermore, E. coli MAGs from chronic pouchitis patients harbored a greater number of plasmids, with an increased presence of plasmid-borne ARGs conferring resistance to antibiotics commonly administered in this group, relative to the other cohorts.

Conclusion

These findings demonstrate that the composition of the ileal pouch microbiome—both in chronic pouchitis and normally functioning IPAA—differs significantly from that of individuals with normal gut physiology. This suggests that the microbiome of a normally functioning IPAA may serve as a more appropriate baseline for comparative studies than the healthy gut microbiome. Additionally, our results indicate that antibiotic use exerts increased selective pressure on E. coli strains carrying antibiotic resistance genes, directly correlating with the types of antibiotics administered.

References

1. Hata K, Ishihara S, Nozawa H, et al. Pouchitis after ileal pouch-anal anastomosis in ulcerative colitis: Diagnosis, management, risk factors, and incidence. Dig Endosc 2017;29:26–34.
2. Shen B, Kochhar GS, Rubin DT, et al. Treatment of pouchitis, Crohn’s disease, cuffitis, and other inflammatory disorders of the pouch: consensus guidelines from the International Ileal Pouch Consortium. Lancet Gastroenterol Hepatol 2021;7:69–95.
3. Herfarth H, Barnes EL, Long MD, et al. Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment. Inflamm Intest Dis 2019;4:1–6.
4. Karjalainen EK, Renkonen-Sinisalo L, Satokari R, et al. Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial. Inflamm Bowel Dis 2021;27:1766–1772.
5. Kousgaard SJ, Cold F, Halkjær SI, et al. The effect of non-pooled multi-donor faecal microbiota transplantation for inducing clinical remission in patients with chronic pouchitis: Results from a multicentre randomised double-blinded placebo-controlled trial (MicroPouch). J Crohn’s Colitis 2024;18:1753–1766.

THE RESISTANT MICROBIOME: INSIGHTS FROM POUCHITIS AND HEALTHY ILEAL POUCHES

Sabrina Kousgaard 1, Alberte Holm Møllekær 2, Sebastian Mølvang Dall 2, Lone Larsen 3, Mads Albertsen 2, Ole Thorlacius-Ussing 4

1 Aalborg University Hospital, Aalborg, Denmark|||Aalborg University Hospital, Aalborg, Denmark

2 Aalborg University, Aalborg, Denmark

3 Aalborg University Hospital, Aalborg, Denmark|||Aalborg University, Copenhagen, Denmark

4 Aalborg University Hospital, Aalborg, Denmark

Event

UEG Week Berlin 2025

Topics

Colorectal Gut Microbiota Mechanisms & Personalised Medicine IBD

Submission format

Abstract

Session

Dissecting the microbiome in gut inflammation

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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

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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

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

1 Onco3R Therapeutics, Leuven, Belgium

2 Galapagos NV, Mechelen, Belgium

3 Novalix, Romainville, France

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

UEG Presentation

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ESOPHAGEAL FUNCTION TESTING IDENTIFIES ASYMPTOMATIC BARRETT’S ESOPHAGUS PATIENTS WITH PATHOLOGICAL ACID EXPOSURE AT RISK FOR NEOPLASIA: A MULTICENTER STUDY

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Introduction

Pathological esophageal acid exposure may persist in patients with Barrett’s esophagus (BE) despite standard proton pump inhibitor (PPI) therapy and symptom control, although current guidelines recommend at least standard-dose PPI for all patients with BE.¹

Aims & Methods

Aim was to evaluate the role of esophageal function testing in assessing acid exposure in BE patients on PPI therapy and in predicting neoplastic progression. We conducted a multicenter retrospective study including asymptomatic BE patients (defined by GerdQ total score <8 and a score of 0 on the first GerdQ item) who underwent high-resolution manometry and 24-hour pH impedance monitoring while on various PPI regimens. Maximal PPI therapy included esomeprazole 40 mg, pantoprazole 40 mg, rabeprazole 20 mg, or lansoprazole 30 mg, all administered twice daily. All other regimens were considered standard dosing. Index upper endoscopy with biopsies was performed under the same therapeutic regimen. Histologically, presence and degree of neoplasia (all confirmed by a second pathologist) was recorded. Acid exposure time (AET) <4% was defined as adequate acid control; AET >6% as pathological reflux. Predictors of pathological reflux and neoplasia were assessed using logistic regression analysis.

Results

A total of 135 patients (2016-2025) were included (mean age 58 ± 15 years; 73% male). Median BE length was C1 (range 0–3 cm) and M2 (range 1–5 cm), with 41% (n=56) classified as having long-segment BE. Sixty-seven patients (50%) were on standard-dose PPI. Pathological reflux was identified in 37 patients (27%), of whom 25 (67%) were on standard-dose therapy. Fourteen patients (10%) had borderline AET values (4–6%). Among the 84 patients (62%) with adequate acid control, 33 (39%) were taking standard-dose PPI. On multivariable analysis, standard-dose PPI (OR 3.04; 95% CI 1.34–6.89; p=0.008) and type III esophagogastric junction morphology (OR 2.52; 95% CI 1.01–5.01; p=0.047), consistent with manometric hiatal hernia, were independently associated with pathological reflux. Non-dysplastic BE was found in 112 patients, while 13 (10%) had neoplasia at index endoscopy (8 low-grade dysplasia, 3 high-grade dysplasia, 2 intramucosal adenocarcinoma). Pathological reflux was the only independent predictor of neoplasia (OR 10.41; 95% CI 2.65–41.26; p<0.001).

Table 1. Logistic regression analysis for factors associated with neoplasia on index endoscopy.

	Univariable analysis		Multivariable analysis
	OR (95% CI)	p-value	OR (95% CI)	p-value
Age, years	1.01 (0.96-1.05)	0.695	-	-
BMI, kg/m²	0.95 (0.83-1-10)	0.957	-	-
Male gender	0.71 (0.19-2.54)	0.783	-	-
PPI standard dose vs maximal	0.85 (0.27-2.69)	0.792	-	-
Long-segment BE vs short	1.70 (0.53-5.52)	0.371	-	-
Ineffective/absent contractility vs normal	0.96 (0.30-3.03)	0.939	-	-
EGJ type III morphology vs I/II	3.98 (1.16-13.71)	0.028	3.18 (0.86-11.78)	0.082
AET >6% vs <6%	11.72 (3.01-45.65)	0.001	10.41 (2.65-41.26)	<0.001

Conclusion

Nearly one-third of asymptomatic BE patients exhibit pathological reflux on pH-monitoring despite PPI treatment, predominantly among those on standard-dose and with manometric hiatal hernia. Nonetheless, adequate acid control is achieved in over one-third of patients on standard PPI therapy. Pathological reflux is associated with a 10-fold increased risk of neoplasia.

References

1. Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. Am J Gastroenterol. 2022;117(4):559-587.