NCT06381219 Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial
| NCT ID | NCT06381219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Eosinophilic Esophagitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-12-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE.
Eligibility Criteria
Inclusion Criteria: All children (aged 12 months and older) presenting (since 1-1-2014: moment of diagnostic guideline standardization for pedEoE) with diagnosed pedEoE at UZ Leuven eliminating either hen's egg or cow's milk or both and in complete remission after their latest biopsy (no longer than 12 months earlier, but preferentially as short as possible after their latest biopsy) are eligible for the study. If the last biopsy has been performed more than 12 months earlier, a new gastro-duodenoscopy will be performed to verify remission and rule out e.g. active gastritis. If they are on PPI and/or local budesonide treatment, this should be stable for at least 3 months and will remain untouched during the entire study. We will include 18 pedEoE subjects suffering from cow's milk induced EoE and 18 suffering from hen's egg induced EoE. Exclusion Criteria: * Children younger than 12 months * Children with active pedEoE * Children who refuse to adhere to the protocol * Children with ass
Frequently Asked Questions
Who can join the NCT06381219 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 18 Years, studying Eosinophilic Esophagitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06381219 currently recruiting?
Yes, NCT06381219 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universitaire Ziekenhuizen KU Leuven to inquire about joining.
Where is the NCT06381219 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06381219 clinical trial?
NCT06381219 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 36 participants.