Skip to main content
OpenTrials
Completed

NCT Number: NCT04626609

Prostaglandin and Cannabinoid Receptors in EoE

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eosinophilic Esophagitis (EoE) Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy samples

Other

Esophageal mucosal biopsies are collected during gastroscopy

Blood Samples

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Disease activity Score

    Time frame: within 48 months

    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.

  2. Endoscopic Reference Score

    Time frame: within 48 months

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Prostaglandin and Cannabinoid Receptors in the Development of Eosinophilic Esophagitis

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2020
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.