ClinicalTrials.gg
CompletedNCT07772388Updated Aug 19, 2026

New Cases of EoE in Children in Poland.

An observational study in Eosinophilic Disorder, Eosinophilic Esophagitis (EoE) and Eosinophilic Disease, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Primary conditionEosinophilic EsophagitisRegistry: EosinophiliaReclassifiedWhy we changed it
Registry
Eosinophilia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Eosinophilic Esophagitis
Why
  1. The study's listed conditions name Eosinophilic Esophagitis, a narrower term within Eosinophilia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medical University of Warsaw · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Eosinophilic Disorder
  • Eosinophilic Esophagitis (EoE)
  • Eosinophilic Disease
  • Pediatric
  • Gastroenterology

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Keywords

  • eosinophilic esophagitis
  • incidence of EoE
  • EoE
  • pediatric EoE
03

In context

Eosinophilic Esophagitis Reclassified

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

This study's enrollment of 250 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.

Compared within Eosinophilic Esophagitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Eosinophilia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age \< 18 years,
  • diagnosis of EZP based on medical history and histopathological examination of esophageal 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

Exclusion Criteria:

  • age > 18 years,
  • inability of parents or guardians to give ,
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Children in Poland with new diagnoses of EoE

    Patients from all over Poland with newly diagnosed eosinophilic esophagitis aged 0 to 18 will be included in the registry, initially from 1 June 2024, to 31 May 2025, and then until 31 May 31 2026.

    Other: Data collection

Interventions

  • OtherData collection

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

07

Study locations

1 site
  • Department of Paediatric Gastroenterology and Nutrition, Medical University of Warsaw
    Warsaw, 02-091, Poland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in May 2025, 11 months.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's 11 months is below that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 19, 2026
StartActual
Jun 1, 2024
Primary completionActual
May 31, 2025
CompletionActual
May 31, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07772388
Responsible party
Aleksandra Banaszkiewicz (Prof. Aleksandra Banaszkiewicz, MD, PhD, Medical University of Warsaw) — Principal investigator
First posted
Aug 19, 2026
Start date
Jun 1, 2024
Primary completion
May 31, 2025
Completion
May 31, 2026
Last update
Aug 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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