The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07770126

Acronym

HELIS

Enrollment

150

Registered

2026-08-18

Start date

2025-02-24

Completion date

2028-03-01

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Gastritis, Dysplasia Stomach, Functional Dyspepsia, Gastric Cancer (GC), Gastritis, Gastritis Chronic, Helicobacter Infection, Intestinal Metaplasia of Gastric Mucosa, NHPH Prevalence

Brief summary

The goal of this clinical trial is to discover the prevalence of NHPH bacteria (Non-Helicobacter pylori Helicobacter species) in patients with one of the following conditions: 1. Functional dyspepsia following the Rome IV criteria 2. Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia 3. Gastric cancer, including siewert type 2 and 3 esophagastric junction cancers In addition, patients undergoing bariatric surgery are included as a control group. This study will be conducted using a prospective analysis in the three targeted study populations. Biopsy specimens routinely taken during the medical procedure or via the resected material in patients belonging to the target groups will be used. Exclusion criteria: * Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples. * Pregnancy. * Underage patients (\< 18 years).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* part of the study population

Exclusion criteria

* Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples. * Pregnancy. * Underage patients (\< 18 years).

Design outcomes

Primary

Measure	Time frame
What is the prevalence of NHPH in patients with (pre)malignant gastric lesions	During the 1st (and only visit)

Secondary

Measure	Time frame	Description
Impact of NHPH infection on the mucin gene expression	During the 1st (and only visit)	What is the impact of NHPH presence on the mucin gene expression in the gastric antrum and corpus in the three abovementioned patient groups? Therefore, differential expression of mRNA (isoform) expression of a mucin gene set will be performed by targeted long-read and bulk short-read sequencing allowing to identify all mucins that are expressed in the three target groups.

Countries

Belgium

Contacts

CONTACTJona Verstraelen, Master

Jona.Verstraelen@uantwerpen.be+32 32 65 14 28

CONTACTEveline Vanheasebrouck, Nurse

studies.gastroenterologie@uza.be+32 3 821 23 82

Outcome results