Prostaglandin and Cannabinoid Receptors in EoE
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Other: Biopsy samplesOther: Blood samples
- Registration Number
- NCT04626609
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- diagnosed or suspected EoE or GERD
- without esophageal diseases
- with signed informed consent
- viral or parasitic diseases (e.g. herpes, candidiasis)
- eosinophilic gastroenteritis, hypereosinophilic syndrome, Crohn's disease
- autoimmune diseases
- unable to give informed consent
- immunosuppressive therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EoE group Biopsy samples Patients with confirmed eosinophilic esophagitis Control group Blood samples Individuals with no esophageal disease GERD group Blood samples Patients with gastro-esophageal reflux disease Control group Biopsy samples Individuals with no esophageal disease EoE group Blood samples Patients with confirmed eosinophilic esophagitis GERD group Biopsy samples Patients with gastro-esophageal reflux disease
- Primary Outcome Measures
Name Time Method Analysis of cannabinoid receptors- protein content 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.
Analysis of cannabinoid receptors- transcripts 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.
Analysis of prostaglandin D2 receptors- protein content 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.
Analysis of prostaglandin D2 receptors - transcripts 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.
Analysis of prostaglandin E2 receptors- protein content 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.
Analysis of prostaglandin E2 receptors- transcripts 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 Outcome Measures
Name Time Method Disease activity Score 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.Endoscopic Reference Score 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.
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Austria