Ireland
--:--IST
Recruiting Not applicable

Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial

NCT06381219 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2023-12-19
Last updated
2026-05-05

Condition(s) studied

Eosinophilic Esophagitis

Investigational drug(s) / intervention(s)

Implementation of cow's milk in decreasingly heated formsImplementation of hen's egg in decreasingly heated forms

Implementation of cow's milk in decreasingly heated forms: Implementation of cow's milk in decreasingly heated forms to assess maintained remission of EoE

Implementation of hen's egg in decreasingly heated forms: Implementation of hen's egg in decreasingly heated forms to assess maintained remission of EoE

Study 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

Sex
ALL
Min age
12 Months
Max age
18 Years
Healthy volunteers
No
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 associated IgE mediated hen's egg and/or cow's milk allergy with specific IgE antibody titers that predict active (baked egg and/or baked milk) food allergy with cut-off titers as used at the consultation of allergy (KLL). Those children will become eligible however if their titers decrease while the study is still open.

Primary outcome measure(s)

  • Maintained remission of EoE — 40 weeks
    Primary end-point of the study is to study the number of pedEoE children by inclusion on hen's egg and/or cow's milk free diet with potential remaining remission (\<15 eosinophils/hpf on esophageal biopsies) after 8 weeks (re)introduction of heat-denatured hen's egg and/or cow's milk proteins (introduced sequentially as on the one hand baked egg (cake), hard-boiled egg, omelet and soft-boiled egg and on the other hand 20' cooked cow's milk, 15', 10' and 5' cooked cow's milk).

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Gasthuisberg Leuven Vlaams-Brabant Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06381219 on ClinicalTrials.gov ↗ ← All trials in Belgium