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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
- ClinicalTrials.gov ID
- NCT07770126
- Acronym / sponsor ID
- HELIS / B3002024000007
- Conditions
- Functional Dyspepsia, Gastritis, Gastritis Chronic, Gastric Cancer (GC), Atrophic Gastritis, Intestinal Metaplasia of Gastric Mucosa
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, General Hospital Groeninge
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- part of the study population
Key exclusion criteria (3 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
What is the prevalence of NHPH in patients with (pre)malignant gastric lesions
Time frame: During the 1st (and only visit)
1 secondary outcome
Impact of NHPH infection on the mucin gene expression
Time frame: During the 1st (and only visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and Gastritis, run by Universiteit Antwerpen at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jona Verstraelen, Master (+32 32 65 14 28, Jona.Verstraelen@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the prevalence of NHPH in patients with (pre)malignant gastric lesions (time frame: During the 1st (and only visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.