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 volunteersQualifiers
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
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
What is the prevalence of NHPH in patients with (pre)malignant gastric lesions
Secondary outcomes
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.
Other outcomes
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).
Sponsors and contacts
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Universiteit Antwerpen
Lead sponsor
University Hospital, Antwerp
Collaborator
Algemeen Ziekenhuis Maria Middelares
Collaborator
General Hospital Groeninge
Collaborator