Prostaglandin and Cannabinoid Receptors in EoE

NCT04626609 | Completed

• 1 other identifier: KLI 887-B
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eosinophilic Esophagitis (EoE)

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Disease activity Score

  within 48 months

• Endoscopic Reference Score

  within 48 months

Study Arms (3)

EoE group

Patients with confirmed eosinophilic esophagitis

Other: Biopsy samples; Other: Blood samples

GERD group

Patients with gastro-esophageal reflux disease

Other: Biopsy samples; Other: Blood samples

Control group

Individuals with no esophageal disease

Other: Biopsy samples; Other: Blood samples

Interventions

Biopsy samples OTHER

Esophageal mucosal biopsies are collected during gastroscopy

Control group; EoE group; GERD group

Blood samples OTHER

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

Control group; EoE group; GERD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing gastroscopy at the outpatients clinic of the Medical University of Graz

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum biopsies

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rudolf Schicho, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: July 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 18, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)