Functional DyspepsiaHELISNCT07770126
The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
An observational study of Functional Dyspepsia and Gastritis, run by Universiteit Antwerpen at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Gastritis, Gastritis Chronic
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 3 sitesBelgium
- Study dates
- 24 Feb 2025to Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- part of the study population
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
UZA
Edegem, 2650
Jona Verstraelen, Master, +32 32 65 14 28, Jona.Verstraelen@uantwerpen.be
Eveline Vanhaesebrouck, Nurse, +32 3 821 23 82, studies.gastroenterologie@uza.be
- Recruiting
AZ Maria Middelares
Ghent, 9000
Margaux Vansteelant, +32 9 246 71 84, Margaux.Vansteelant@mijnziekenhuis.be
Tine Delvaeye, +32 9 246 71 84, Tinneke.Delvaeye@mijnziekenhuis.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
Janne Verschaete, +32 56 63 33 36, janne.verschaete@azgroeninge.be
Wouter Van Moerkercke, MD
About this study
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:
- Functional dyspepsia following the Rome IV criteria
- Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia
- 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.
Read more
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).
- Conditions
- Functional Dyspepsia, Gastritis, Gastritis Chronic, Gastric Cancer (GC), Atrophic Gastritis, Intestinal Metaplasia of Gastric Mucosa
- Medical subject headings
- Gastritis, Stomach Neoplasms, Gastritis, Atrophic, Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the prevalence of NHPH in patients with (pre)malignant gastric lesions
Measured: 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.
Measured: During the 1st (and only visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start24 Feb 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, General Hospital Groeninge
- Responsible party
- Principal investigator, Jona Verstraelen, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770126
- Sponsor's protocol ID
- B3002024000007
- Other IDs
- B3002024000007, 003277
- Acronym
- HELIS
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided