ClinicalTrials.gg
RecruitingNCT07770126HELISUpdated Aug 18, 2026

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

An observational study in Functional Dyspepsia, Gastritis and Gastritis Chronic, sponsored by Universiteit Antwerpen. Recruiting at 3 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Primary conditionGastritis, AtrophicRegistry: GastritisReclassifiedWhy we changed it
Registry
Gastritis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Gastritis, Atrophic
Why
  1. The study's listed conditions name Gastritis, Atrophic, a narrower term within Gastritis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universiteit Antwerpen · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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:

  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).
02

Conditions studied

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

Browse trials for

03

In context

Gastritis, Atrophic Reclassified

75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.

This study's planned enrollment of 150 is below the median of 509 across 54 observational studies indexed under Gastritis, Atrophic.

Browse Gastritis, Atrophic studies →

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.

Compared within Gastritis, Atrophic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • part of the study population

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of H. pylori infection diagnosed by serology, on gastric , by breath test or on antigen test in stool samples.
  • Pregnancy.
  • Underage patients (\< 18 years).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

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)

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Mar 2028, 37 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 18, 2026
StartActual
Feb 24, 2025
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07770126
Collaborators
University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, General Hospital Groeninge
Responsible party
Jona Verstraelen (PhD candidate, Universiteit Antwerpen) — Principal investigator
First posted
Aug 18, 2026
Start date
Feb 24, 2025
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 18, 2026

Study contacts

Jona Verstraelen, Master
Contact
Jona.Verstraelen@uantwerpen.be
+32 32 65 14 28
Eveline Vanheasebrouck, Nurse
Contact
studies.gastroenterologie@uza.be
+32 3 821 23 82

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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