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NCT Number: NCT07770126

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

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).

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Key information

Conditions

Functional Dyspepsia Atrophic Gastritis Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Digestive System Neoplasms Dysplasia Stomach Gastric Cancer (GC) Gastritis Gastritis Chronic Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Gram-Negative Bacterial Infections Helicobacter Infection Helicobacter Infections Infections Intestinal Metaplasia of Gastric Mucosa NHPH Prevalence Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZA, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

    Time frame: 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.

Other outcomes

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

    Time frame: During the 1st (and only visit)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eveline Vanheasebrouck, Nurse

CONTACT

[email protected]

+32 3 821 23 82

Jona Verstraelen, Master

CONTACT

[email protected]

+32 32 65 14 28

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Algemeen Ziekenhuis Maria Middelares
  • General Hospital Groeninge
  • University Hospital, Antwerp

Registry information

Acronym: HELIS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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