Prostaglandin and Cannabinoid Receptors in EoE

Eosinophilic Esophagitis (EoE) Clinical Trial

Official title:

Prostaglandin and Cannabinoid Receptors in the Development of Eosinophilic Esophagitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626609
• Other study ID #: KLI 887-B
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: February 2025

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: Rudolf Schicho, PhD
• Phone: +43316385
• Email: rudolf.schicho[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Esophagitis

Intervention

Other:
• Biopsy samples
Esophageal mucosal biopsies are collected during gastroscopy
• Blood samples
Blood will be drawn by venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing vacutainer tubes and into serum tubes

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 48 months
Primary	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.	within 48 months
Primary	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.	within 48 months
Primary	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.	within 48 months
Primary	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.	within 48 months
Primary	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.	within 48 months
Secondary	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.	within 48 months
Secondary	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.	within 48 months