Prostaglandin and Cannabinoid Receptors in EoE

NCT ID: NCT04626609

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-11-18

Brief Summary

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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

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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

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Eosinophilic Esophagitis (EoE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EoE group

Patients with confirmed eosinophilic esophagitis

Biopsy samples

Intervention Type OTHER

Esophageal mucosal biopsies are collected during gastroscopy

Blood samples

Intervention Type OTHER

Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes

GERD group

Patients with gastro-esophageal reflux disease

Biopsy samples

Intervention Type OTHER

Esophageal mucosal biopsies are collected during gastroscopy

Blood samples

Intervention Type OTHER

Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes

Control group

Individuals with no esophageal disease

Biopsy samples

Intervention Type OTHER

Esophageal mucosal biopsies are collected during gastroscopy

Blood samples

Intervention Type OTHER

Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes

Interventions

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Biopsy samples

Esophageal mucosal biopsies are collected during gastroscopy

Intervention Type OTHER

Blood samples

Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed or suspected EoE or GERD
* without esophageal diseases
* with signed informed consent

Exclusion Criteria

* viral or parasitic diseases (e.g. herpes, candidiasis)
* eosinophilic gastroenteritis, hypereosinophilic syndrome, Crohn's disease
* autoimmune diseases
* unable to give informed consent
* immunosuppressive therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudolf Schicho, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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KLI 887-B

Identifier Type: -

Identifier Source: org_study_id

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