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Prostaglandin and Cannabinoid Receptors in EoE

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04626609
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Graz
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rudolf Schicho, PhD
Principal Investigator Affiliation Medical University of Graz
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Austria
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis (EoE)
Additional Details

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.

Arms & Interventions

Arms

: EoE group

Patients with confirmed eosinophilic esophagitis

: GERD group

Patients with gastro-esophageal reflux disease

: Control group

Individuals with no esophageal disease

Interventions

Other: - Biopsy samples

Esophageal mucosal biopsies are collected during gastroscopy

Other: - Blood samples

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

Contact a Trial Team

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International Sites

Medical University of Graz, Graz, Austria

Status

Recruiting

Address

Medical University of Graz

Graz, , 8036

Site Contact

Durchschein Franziska, MD

rudolf.schicho@medunigraz.at

+43316385

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