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

NCT07770126 | Recruiting

• 2 other identifiers: B3002024000007003277
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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:

• 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• What is the prevalence of NHPH in patients with (pre)malignant gastric lesions

  During the 1st (and only visit)

Secondary Outcomes (1)

• Impact of NHPH infection on the mucin gene expression

  During the 1st (and only visit)

Other Outcomes (1)

• Finding non-invasive testing of NHPH using saliva, feces, blood samples and breath samples

  During the 1st (and only visit)

Study Arms (4)

Functional dyspepsia

Functional dyspepsia following the Rome IV criteria

Gastritis

Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia

Gastric cancer

Gastric cancer, including siewert type 2 and 3 esophagastric junction cancers

Control

Patients undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with (pre)malignant gastric lesions 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 And as a control group, patient undergoing bariatric surgery are included

You may qualify if:

• part of the study population

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator
• General Hospital Groeninge: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator

Study Sites (3)

UZA

Edegem, 2650, Belgium

RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample (EDTA), will be divided into 500 uL aliquots and stored in 1.5 ml Eppendorf tubes (minimal 3 tubes). These samples will be used for the extraction of DNA and/or RNA on which sequencing (eg. Illumina and/or Pacbio sequencing) will be performed to identify NHPH infection, mucin profiles, genes associated with barrier function. Biopsy specimens are collected during of after the medical procedure, from the resected material or from a region with signs of inflammation, damage, irritation, ulcers or bleeding (if present) and that same region but without signs of inflammation. Also a brush biopsy, used in gastrointestinal disease endoscopy (e.g. Barrett) will be taken to minimize sampling errors (cfr. NHPH are sparce dsitributed). DNA and RNA will be extracted from the biopsies and brush.

MeSH Terms

Conditions

Gastritis; Stomach Neoplasms; Gastritis, Atrophic; Helicobacter Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Jona Verstraelen, Master

CONTACT

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

Eveline Vanheasebrouck, Nurse

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: February 24, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

BE (3)