Eosinophilic DisorderNCT07772388
New Cases of EoE in Children in Poland.
An observational study of Eosinophilic Disorder and Eosinophilic Esophagitis (EoE), run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eosinophilic Disorder, Eosinophilic Esophagitis (EoE), Eosinophilic Disease
- What is being tested?
- Data collection
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2024to 31 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ddd
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatric Gastroenterology and Nutrition, Medical University of Warsaw
Warsaw, 02-091
About this study
Official title: Register of New Diagnoses of Eosinophilic Esophagitis 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.
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.
- Conditions
- Eosinophilic Disorder, Eosinophilic Esophagitis (EoE), Eosinophilic Disease, Pediatric, Gastroenterology
- Being tested
- Data collection
- Keywords
- eosinophilic esophagitis, incidence of EoE, EoE, pediatric EoE
- Medical subject headings
- Eosinophilia, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of Polish pediatric patients
Characteristics of Polish patients with EZP, f.e., their demographic, clinical, endoscopic and histological features.
Measured: June 2024 - May 2026
Incidence of EoE in children in Poland.
Assessment of the incidence of EZP in Poland in the pediatric population.
Measured: 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.
Measured: June 2024 - May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jun 2024
- Primary completion31 May 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Banaszkiewicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772388
- Sponsor's protocol ID
- NewEoE
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of New Diagnoses of Eosinophilic Esophagitis in Children in Poland.
- ClinicalTrials.gov ID
- NCT07772388
- Acronym / sponsor ID
- NewEoE
- Conditions
- Eosinophilic Disorder, Eosinophilic Esophagitis (EoE), Eosinophilic Disease, Pediatric, Gastroenterology
- Keywords
- eosinophilic esophagitis, incidence of EoE, EoE, pediatric EoE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children in Poland with new diagnoses of EoE | – | Other: Data collectionPatients 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ddd
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionPatient 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. | Other | Children in Poland with new diagnoses of EoE |
Primary outcome
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.
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.
1 secondary outcome
Improving the efficiency of proposed diagnostic and therapeutic protocols
Time frame: June 2024 - May 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Disorder and Eosinophilic Esophagitis (EoE), run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of Polish pediatric patients (time frame: June 2024 - May 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.