Eosinophilic Esophagitis (EoE)NCT04626609
Prostaglandin and Cannabinoid Receptors in EoE
An observational study of Eosinophilic Esophagitis (EoE), run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of this study is to investigate prostaglandin and cannabinoid receptors and their endogenous ligands in eosinophilic esophagitis (EoE). A prostaglandin D2 receptor antagonist has been shown to improve disease symptoms suggesting a regulatory role for bioactive lipids in EoE. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Biopsy samples and Blood samples
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2021to 18 Nov 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects undergoing gastroscopy at the outpatients clinic of the Medical University of Graz
Who may be able to join
- diagnosed or suspected EoE or GERD
- without esophageal diseases
- with signed informed consent
Who cannot join
- viral or parasitic diseases (e.g. herpes, candidiasis)
- eosinophilic gastroenteritis, hypereosinophilic syndrome, Crohn's disease
- autoimmune diseases
- unable to give informed consent
- immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostaglandin and Cannabinoid Receptors in the Development of Eosinophilic Esophagitis
The purpose of this study is to investigate prostaglandin and cannabinoid receptors and their endogenous ligands in eosinophilic esophagitis (EoE). A prostaglandin D2 receptor antagonist has been shown to improve disease symptoms suggesting a regulatory role for bioactive lipids in EoE. Prostaglandin D2 and E2, and endocannabinoids are lipid mediators that govern the functional and inflammatory behavior of immune cells critical for EoE development. The prostaglandin D2 and E2 receptor axis, and the components of the endocannabinoid may be involved in the pathogenesis of EoE.
Read the detailed description
Prostaglandin D2 and E2 receptors, and components of the endocannabinoid system (cannabinoid receptors and endocannabinoid-metabolizing enzymes) are examined in mucosal esophageal biopsies and blood leukocytes from EoE patients (acute and in remission), individuals with gastroesophageal reflux and from individuals with no esophageal disease. Expression of these components are compared between all cohorts by polymerase chain reaction, Western blots, flow cytometry and immunohistochemical methods. EoE disease activity is evaluated by determining a symptom score and the number of eosinophils per high-power field (hpf) in histologic sections of mucosal biopsies. Additionally, an Endoscopic Reference Score (EREFS) is used. Disease activity is correlated with cannabinoid/prostaglandin D2 and E2 receptor expression. Blood is collected and immediately processed for flow cytometric experiments. Prostaglandins and endocannabinoids are measured in plasma and esophageal mucosal biopsy samples of all cohorts by mass spectrometry.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Biopsy samples, Blood samples
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy samplesOther
Esophageal mucosal biopsies are collected during gastroscopy
Blood samplesOther
Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes
| Study group | Role | What they receive |
|---|---|---|
| EoE group | Patients with confirmed eosinophilic esophagitis Receives: Other: Biopsy samples; Other: Blood samples | |
| GERD group | Patients with gastro-esophageal reflux disease Receives: Other: Biopsy samples; Other: Blood samples | |
| Control group | Individuals with no esophageal disease Receives: Other: Biopsy samples; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of cannabinoid receptors- protein content
Cannabinoid receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Measured: within 48 months
Analysis of cannabinoid receptors- transcripts
Transcripts of cannabinoid receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
Measured: within 48 months
Analysis of prostaglandin D2 receptors- protein content
Prostaglandin D2 receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Measured: within 48 months
Analysis of prostaglandin D2 receptors - transcripts
Transcripts of prostaglandin D2 receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
Measured: within 48 months
Analysis of prostaglandin E2 receptors- protein content
Prostaglandin E2 receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Measured: within 48 months
Analysis of prostaglandin E2 receptors- transcripts
Transcripts of prostaglandin E2 receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
Measured: within 48 months
Secondary outcomes (2)
Disease activity Score
Assessment of a Disease Activity Score:
The Disease Activity Score will be assessed on the basis of the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument (Dis Esophagus. 2007;20 (2):130-4) and consists of a questionnaire rated from 0 to 5 where 0 indicates no symptoms while 5 indicates strong symptoms of heartburn and difficulties in swallowing that incapacitates to do daily activities.
Measured: within 48 months
Endoscopic Reference Score
Assessment of an Endoscopic Reference Score:
Endoscopic findings will be assessed using the EoE Endoscopic Reference Score (EREFS) (Hirano et al. Gut. 2013; 62:489-495) which is composed of 5 classification categories. The classification features include edema, fixed rings, exsudates, furrows and stricture where grade 0 indicates the absence of the feature and grade 2 and 3 increasing severity of the feature.
Measured: within 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Schicho, PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626609
- Sponsor's protocol ID
- KLI 887-B
- Status last verified
- Apr 2025
- First submitted
- 6 Nov 2020
- Last updated
- 2 May 2025
- Results posted
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandin and Cannabinoid Receptors in the Development of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04626609
- Acronym / sponsor ID
- KLI 887-B
- Conditions
- Eosinophilic Esophagitis (EoE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 12 Nov 2020 (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 purpose of this study is to investigate prostaglandin and cannabinoid receptors and their endogenous ligands in eosinophilic esophagitis (EoE). A prostaglandin D2 receptor antagonist has been shown to improve disease symptoms suggesting a regulatory role for bioactive lipids in EoE. Prostaglandin D2 and E2, and endocannabinoids are lipid mediators that govern the functional and inflammatory behavior of immune cells critical for EoE development. The prostaglandin D2 and E2 receptor axis, and the components of the endocannabinoid may be involved in the pathogenesis of EoE.
Detailed description
Prostaglandin D2 and E2 receptors, and components of the endocannabinoid system (cannabinoid receptors and endocannabinoid-metabolizing enzymes) are examined in mucosal esophageal biopsies and blood leukocytes from EoE patients (acute and in remission), individuals with gastroesophageal reflux and from individuals with no esophageal disease. Expression of these components are compared between all cohorts by polymerase chain reaction, Western blots, flow cytometry and immunohistochemical methods. EoE disease activity is evaluated by determining a symptom score and the number of eosinophils per high-power field (hpf) in histologic sections of mucosal biopsies. Additionally, an Endoscopic Reference Score (EREFS) is used. Disease activity is correlated with cannabinoid/prostaglandin D2 and E2 receptor expression. Blood is collected and immediately processed for flow cytometric experiments. Prostaglandins and endocannabinoids are measured in plasma and esophageal mucosal biopsy samples of all cohorts by mass spectrometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EoE group | – | Other: Biopsy samples, Other: Blood samplesPatients with confirmed eosinophilic esophagitis |
| GERD group | – | Other: Biopsy samples, Other: Blood samplesPatients with gastro-esophageal reflux disease |
| Control group | – | Other: Biopsy samples, Other: Blood samplesIndividuals with no esophageal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing gastroscopy at the outpatients clinic of the Medical University of Graz
Key inclusion criteria (3 listed)
- diagnosed or suspected EoE or GERD
- without esophageal diseases
- with signed informed consent
Key exclusion criteria (5 listed)
- viral or parasitic diseases (e.g. herpes, candidiasis)
- eosinophilic gastroenteritis, hypereosinophilic syndrome, Crohn's disease
- autoimmune diseases
- unable to give informed consent
- immunosuppressive therapy
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 |
|---|---|---|
| Biopsy samplesEsophageal mucosal biopsies are collected during gastroscopy | Other | Control group, EoE group, GERD group |
| Blood samplesBlood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes | Other | Control group, EoE group, GERD group |
Primary outcome
Analysis of cannabinoid receptors- protein content
Time frame: within 48 months
Cannabinoid receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Analysis of cannabinoid receptors- transcripts
Time frame: within 48 months
Transcripts of cannabinoid receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
Analysis of prostaglandin D2 receptors- protein content
Time frame: within 48 months
Prostaglandin D2 receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Analysis of prostaglandin D2 receptors - transcripts
Time frame: within 48 months
Transcripts of prostaglandin D2 receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
Analysis of prostaglandin E2 receptors- protein content
Time frame: within 48 months
Prostaglandin E2 receptors (protein) are measured by flow cytometry in blood leukocytes of patients with EoE (acute and in remission), and of control individuals.
Analysis of prostaglandin E2 receptors- transcripts
Time frame: within 48 months
Transcripts of prostaglandin E2 receptors are measured in esophageal mucosal biopsies of patients with EoE (acute and in remission), GERD and in control individuals by polymerase chain reaction.
2 secondary outcomes
Disease activity Score
Time frame: within 48 months
Endoscopic Reference Score
Time frame: within 48 months
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 2 May 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.
Rudolf Schicho, PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis (EoE), run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 5 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 2 May 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 Austria. 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?
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?
Analysis of cannabinoid receptors- protein content (time frame: within 48 months). The study lists 6 primary outcomes in all. 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 2 May 2025.