New Cases of EoE in Children in Poland.

Medical University of Warsaw250 enrolled

Overview

The aim of the study is to assess the incidence of EZP in Poland in the pediatric population and characteristics of Polish patients with EZP, i.e. their demographic, clinical, endoscopic and histological features. Another important objective of the study is to identify areas where the diagnosis and treatment of EZP in children can be improved. The study is prospective and non-interventional.

Data will be collected in the REDCap (Research Electronic Data Capture) platform, which ensures the security of collected data and widely used in international clinical trials. All centers performing endoscopic examinations in children in Poland will be invited to participate in the study. One person from each center will be designated to collect data and update the database. The data entered will be regularly updated with the results of follow-up examinations and the effects of treatment of patients by a designated person at the center. The data entered will only include data collected during routine clinical practice. The registry will not contain any data enabling the identification of patients, e.g., home address. Inclusion of data in the registry will not pose any health risks and does not require any tests other than routine ones. Participation in the registry is voluntary and requires the written consent of the parent/legal guardian and/or patient. Participation may be refused without giving a reason, without affecting the patient's treatment. Consent may be changed or withdrawn at any time. The attending physician will inform the patient and parent/legal guardian about the database and explain its value and benefits as well as the rights of participants. In addition, each participant will be provided with an information brochure about the registry.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Eosinophilic Disorder Eosinophilic Esophagitis (EoE)Eosinophilic Disease Pediatric Gastroenterology

Interventions

Data collectionOTHER

Patient data will include information collected during routine clinical practice, e.g., body weight, height, EZP symptoms, allergy symptoms, laboratory test results, endoscopy results, etc. Entering data into the registry will not pose any health risks and does not require any tests beyond routine ones.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \< 18 years, * diagnosis of EZP based on medical history and histopathological examination of esophageal biopsies taken during gastroscopy (≥15 eosinophils/field of view in ≥1 biopsy), * consent of legal guardians and the child (in the case of patients ≥12 years of age) to participate in the study. Exclusion Criteria: * age \> 18 years, * inability of parents or guardians to give informed consent, * patients who did not consent to participate in the study (applies to patients \> 12 years of age), * congenital defects of the gastrointestinal tract, * status after surgery for gastrointestinal cancer.

Locations (1)

Department of Paediatric Gastroenterology and Nutrition, Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

Characteristics of Polish pediatric patients

Characteristics of Polish patients with EZP, f.e., their demographic, clinical, endoscopic and histological features.

Time frame: June 2024 - May 2026

Incidence of EoE in children in Poland.

Assessment of the incidence of EZP in Poland in the pediatric population.

Time frame: June 2024 - May 2026

Secondary Outcomes

Improving the efficiency of proposed diagnostic and therapeutic protocols

Identification of areas where the diagnosis and treatment of EZP in children can be improved.

Time frame: June 2024 - May 2026

Data from ClinicalTrials.gov

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