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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversiteit Antwerpen

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

part of the study population

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 4 trial groups
Group A: Functional dyspepsia
Group B: Gastritis
Group C: Gastric cancer
Group D: Control

Trial outcomes

Primary outcomes

1

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

Time frame
During the 1st (and only visit)

Secondary outcomes

1

Impact of NHPH infection on the mucin gene expression

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.

Time frame
During the 1st (and only visit)

Other outcomes

1

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

What is the diagnostic performance of non-invasive testing of NHPH using saliva samples, fecal samples, blood samples or breath samples to screen for volatile organic compounds (VOCs), compared to standard PCR testing on gastric biopsy? Buccal swabs contain saliva and buccal cells and will be collected to perform PCR assays combined with sequencing. Also, the molecular analysis of exhaled breath containing strain-specific VOCs will be performed using gas chromatography-quadrupole time of flight (GS-QTOF-MS) technology and Ion Mobility Spectrometry (IMS).

Time frame
During the 1st (and only visit)

Sponsors and contacts

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Universiteit Antwerpen

Lead sponsor

University Hospital, Antwerp

Collaborator

Algemeen Ziekenhuis Maria Middelares

Collaborator

General Hospital Groeninge

Collaborator