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NCT07770126 · ClinicalTrials.gov record · last posted 2026-08-18

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

Study acronym: HELIS
StatusRecruiting
PhaseNot specified
Started2025-02-24
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from the ClinicalTrials.gov record
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).
Trial Details
NCT Number NCT07770126
Lead Sponsor Universiteit Antwerpen
Collaborators: University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, General Hospital Groeninge
Conditions Functional Dyspepsia, Gastritis, Gastritis Chronic, Gastric Cancer (GC), Atrophic Gastritis, Intestinal Metaplasia of Gastric Mucosa, Dysplasia Stomach, Helicobacter Infection +1 more
Enrollment 150 participants
Start Date 2025-02-24
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-18