Functional DyspepsiaPhase 4NCT04713969
Neuro-immune Interactions and PPI
A Phase 4 study testing Pantoprazole 40mg in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Pantoprazole 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2021to 23 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with FD diagnosis as per Rome IV criteria (EPS or PDS).
- Normal investigation including upper GI endoscopy.
- Patients have confirmed duodenal mucosal eosinophilia.
- Patients witnessed written informed consent.
- Patients aged between 18 and 64 years inclusive.
- Male or female (not pregnant or lactating and using contraception or postmenopausal).
- Subjects are capable to understand the study and the questionnaires, and to comply with the study requirements.
Who cannot join
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study.
- Patients with any major psychiatric disorders (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications).
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD).
- Patients with personal or family (first-degree relative) of diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, lupus, scleroderma, rheumatic or other systemic auto-immune disease.
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis.
- Active H. pylori infection (or \<6 months after eradication).
Show all 19Show fewer
- Allergy or atopy, including therapy.
- Organic gastro-intestinal disease or history of gastrointestinal surgery other than appendectomy or splenectomy.
- Known impaired liver or kidney dysfunction, or coagulation disorders.
- Known HIV, HBV or HCV infection, including therapy.
- Active coronary or peripheral artery disease.
- Use of anti-inflammatory drugs or anti-allergy drugs \<2 weeks before sampling.
- Use of immunosuppressants, antibiotics or acid-suppressive drugs \<3 months before sampling.
- Use of prokinetics \<2 weeks before sampling (unless if ≤3/week).
- Significant alcohol use (\>10 units/week).
- Any use of alcohol or smoking \<2 days before sampling.
- Active malignancy, including therapy.
- Females who are pregnant or lactating.
- Patients not capable to understand or be compliant with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duodenal Neuro-immune Interactions and Effects of PPI in Functional Dyspepsia
Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI
Read the detailed description
Duodenal low-grade inflammation is frequently reported in functional dyspepsia (FD), while also neuronal and structural changes in duodenal submucosal ganglia have been described in FD patients. Proton pump inhibitors (PPI) are the first-line therapy in FD patients and are recently shown to have anti-inflammatory properties in FD. However, the exact mechanism of their anti-inflammatory action is unknow and their effect on duodenal nerve signalling remain unclear.
In this prospective interventional study, FD patients will undergo study procedures before and after treatment with pantoprazole (Pantomed®) 40mg twice daily during 4 weeks, with a baseline comparison to healthy volunteers.
This study aims to provide an in-deep characterization of the inflammatory infiltrate in the duodenum of FD patients, and to unravel the effect of PPI-therapy on neuronal signalling, duodenal inflammation and neuro-immune interactions in FD.
Novel insights in the pathophysiology of FD, including the duodenal mucosal inflammation and impaired neuronal functioning, can provide a better understanding of this commonly and costly disorder. Moreover, these results will help to elucidate the anti-inflammatory effect of PPI, which will contribute to the discovery of predictive markers for therapeutic efficacy of PPI in FD.
- Conditions
- Functional Dyspepsia
- Being tested
- Pantoprazole 40mg
- Keywords
- inflammation, imaging
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole 40mgDrug
Also called Pantomed
Pantoprazole 40mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia patients before and after PPI | Experimental | Pantoprazole 40mg twice daily in functional dyspepsia patients for 4 weeks Receives: Drug: Pantoprazole 40mg |
| Healthy controls without PPI | No intervention | Baseline investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of PPI on duodenal mucosal inflammation (assessed by flow cytometry on lamina propria leukocytes) in FD
Duodenal mucosal inflammation as assessed by flow cytometric quantification of immune cell populations in isolated lamina propria leukocytes before and after PPI
Measured: 4 weeks
Secondary outcomes (4)
The effect of PPI on symptoms (Patient Assessment of Upper Gastrointestinal Disorders - Symptom severity index [PAGI-SYM]) in FD
PAGI-SYM symptom scores (ranging from 0 [no symptoms] to 5 [very severe symptoms]) before and after PPI
Measured: 4 weeks
The effect of PPI on quality of life (Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life [PAGI-QOL]) in FD
PAGI-QOL scores (ranging from 0 [lowest quality of life] to 5 [highest quality of life]) before and after PPI
Measured: 4 weeks
The effect of PPI on salivary cortisol in FD
salivary cortisol before and after PPI
Measured: 4 weeks
The effect of PPI on systemic inflammation (assessed by flow cytometry) in FD
Systemic inflammation quantified by flow cytometry of peripheral blood leukocytes before and after PPI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start31 Mar 2021
- Primary completion10 Jan 2024
- Study completion23 Sep 2024
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention with PPI (Pantoprazole 40mg twice daily) in 30 FD patients. Baseline procedures in 30 healthy controls.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Vanuytsel, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713969
- Sponsor's protocol ID
- S64807/64847
- Status last verified
- Jun 2024
- First submitted
- 17 Dec 2020
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duodenal Neuro-immune Interactions and Effects of PPI in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT04713969
- Acronym / sponsor ID
- S64807/64847
- Conditions
- Functional Dyspepsia
- Keywords
- inflammation, imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 19 Jan 2021 (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.
Prospective interventional study on duodenal neuro-immune interactions in healthy volunteers and functional dyspepsia patients and the effects of PPI
Detailed description
Duodenal low-grade inflammation is frequently reported in functional dyspepsia (FD), while also neuronal and structural changes in duodenal submucosal ganglia have been described in FD patients. Proton pump inhibitors (PPI) are the first-line therapy in FD patients and are recently shown to have anti-inflammatory properties in FD. However, the exact mechanism of their anti-inflammatory action is unknow and their effect on duodenal nerve signalling remain unclear.
In this prospective interventional study, FD patients will undergo study procedures before and after treatment with pantoprazole (Pantomed®) 40mg twice daily during 4 weeks, with a baseline comparison to healthy volunteers.
This study aims to provide an in-deep characterization of the inflammatory infiltrate in the duodenum of FD patients, and to unravel the effect of PPI-therapy on neuronal signalling, duodenal inflammation and neuro-immune interactions in FD.
Novel insights in the pathophysiology of FD, including the duodenal mucosal inflammation and impaired neuronal functioning, can provide a better understanding of this commonly and costly disorder. Moreover, these results will help to elucidate the anti-inflammatory effect of PPI, which will contribute to the discovery of predictive markers for therapeutic efficacy of PPI in FD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention with PPI (Pantoprazole 40mg twice daily) in 30 FD patients. Baseline procedures in 30 healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia patients before and after PPI | Experimental | Drug: Pantoprazole 40mgPantoprazole 40mg twice daily in functional dyspepsia patients for 4 weeks |
| Healthy controls without PPI | No intervention | –Baseline investigations |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with FD diagnosis as per Rome IV criteria (EPS or PDS).
- Normal investigation including upper GI endoscopy.
- Patients have confirmed duodenal mucosal eosinophilia.
- Patients witnessed written informed consent.
- Patients aged between 18 and 64 years inclusive.
Key exclusion criteria (19 listed)
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study.
- Patients with any major psychiatric disorders (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications).
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD).
- Patients with personal or family (first-degree relative) of diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, lupus, scleroderma, rheumatic or other systemic auto-immune disease.
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole 40mgAlso: PantomedPantoprazole 40mg twice daily | Drug | Functional dyspepsia patients before and after PPI |
Primary outcome
The effect of PPI on duodenal mucosal inflammation (assessed by flow cytometry on lamina propria leukocytes) in FD
Time frame: 4 weeks
Duodenal mucosal inflammation as assessed by flow cytometric quantification of immune cell populations in isolated lamina propria leukocytes before and after PPI
4 secondary outcomes
The effect of PPI on symptoms (Patient Assessment of Upper Gastrointestinal Disorders - Symptom severity index [PAGI-SYM]) in FD
Time frame: 4 weeks
The effect of PPI on quality of life (Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life [PAGI-QOL]) in FD
Time frame: 4 weeks
The effect of PPI on salivary cortisol in FD
Time frame: 4 weeks
The effect of PPI on systemic inflammation (assessed by flow cytometry) in FD
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tim Vanuytsel, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole 40mg in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of PPI on duodenal mucosal inflammation (assessed by flow cytometry on lamina propria leukocytes) in FD (time frame: 4 weeks). 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 28 Jan 2025.