Clinical trial NCT04626609: Prostaglandin and Cannabinoid Receptors in EoE
Official title: Prostaglandin and Cannabinoid Receptors in the Development of Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis (EoE)
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing gastroscopy at the outpatients clinic of the Medical University of Graz

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of cannabinoid receptors- protein content
timeFrame: within 48 months
measure: Analysis of cannabinoid receptors- transcripts
timeFrame: within 48 months
measure: Analysis of prostaglandin D2 receptors- protein content
timeFrame: within 48 months
measure: Analysis of prostaglandin D2 receptors - transcripts
timeFrame: within 48 months
measure: Analysis of prostaglandin E2 receptors- protein content
timeFrame: within 48 months
measure: Analysis of prostaglandin E2 receptors- transcripts
timeFrame: within 48 months
Secondary outcomes:
measure: Disease activity Score
timeFrame: within 48 months
measure: Endoscopic Reference Score
timeFrame: within 48 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Rudolf Schicho, PhD
role: PRINCIPAL_INVESTIGATOR
References: