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OpenTrials
Completed

NCT Number: NCT07772388

New Cases of EoE in Children in Poland.

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.

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Key information

Conditions

Eosinophilic Disorder Digestive System Diseases Eosinophilia Eosinophilic Disease Eosinophilic Esophagitis Eosinophilic Esophagitis (EoE) Esophageal Diseases Esophagitis Gastroenteritis Gastroenterology Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Pediatric

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Paediatric Gastroenterology and Nutrition, Medical University of Warsaw

Warsaw, 02-091, Poland

About this study

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 Consent may be changed or withdrawn at any time.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. Characteristics of Polish pediatric patients

    Time frame: June 2024 - May 2026

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

  2. Incidence of EoE in children in Poland.

    Time frame: June 2024 - May 2026

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

Secondary outcomes

  1. Improving the efficiency of proposed diagnostic and therapeutic protocols

    Time frame: June 2024 - May 2026

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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Register of New Diagnoses of Eosinophilic Esophagitis in Children in Poland.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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